Regulatory Affairs Specialist Resume Samples

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H Gulgowski

Hailee

Gulgowski

71087 Eulah Harbors

Boston

+1 (555) 760 7599

71087 Eulah Harbors

Boston

Phone

p +1 (555) 760 7599

Experience Experience

Philadelphia, PA

Regulatory Affairs Specialist

Philadelphia, PA

Mosciski-Labadie

Philadelphia, PA

Regulatory Affairs Specialist

Be willing to work with a Lean team and wear multiple hats to create smart strategies for regulatory submissions and an expanding Quality Management System
Assist regulatory management in the implementation and delivery of CMC regulatory documentation
Participate in cross-functional teams by working closely with product development engineering, marketing, clinical, and quality functions
Management of new product development and registration projects and for conducting routine regularoty operations to ensure compliance
Assist in developing regulatory strategies
Identify opportunities to implement process and procedural improvements to drive efficiency within a growing digital health organization
Excellent training and development programs as well as opportunities to grow within the company

Houston, TX

Senior Regulatory Affairs Specialist

Houston, TX

Wuckert-Fay

Houston, TX

Senior Regulatory Affairs Specialist

Ensuring collaboration across RSU, including communication with regions and countries
Ensuring overall project efficiency and adherence to project timelines and financial goals
Contributing to the collection, interpretation, analysis and dissemination of accurate regulatory intelligence
Advertising and promotion
Working knowledge of and aptitude for activities related to regulatory affairs and quality assurance, both domestic and international
Assisting with the creation and review of core scientific, technical and administrative documentation
Developing and implementing the RSU Management Plan

present

Dallas, TX

Principal Regulatory Affairs Specialist

Dallas, TX

Fritsch and Sons

present

Dallas, TX

Principal Regulatory Affairs Specialist

present

Assists management in the monitoring of state and federal regulatory and legislative development to identify issues affecting company's operations and plans
Establish and maintain good working relationship with regional RA peers and local business units to gain positive and timely support
Works with Regulatory Affairs Management to determine effective regulatory pathways for a variety of issues
Develop regulatory plans and departmental positioning in collaboration with the Manager and Director of Regulatory Affairs and Design Assurance
Follow all work/quality procedures to ensure quality system compliance and high quality work
Provide regulatory guidance for product development and planning throughout the product lifecycle
Develop worldwide regulatory strategies/plans and lead implementation. Provide on-going expertise to teams for regulatory issues and questions

Education Education

Bachelor’s Degree in Science

Florida Atlantic University

Bachelor’s Degree in Science

Skills Skills

A good knowledge of a number of country specific clinical trial application procedures Expert knowledge of ICH and global regulatory guidelines
Good organizational and time management skills; ability to adhere to timelines
Good knowledge Global Regulatory Affairs Procedures
Producing weekly and monthly regulatory reports for both internal EY stakeholders across service lines as well as external committee chairs and boards, ensuring that material aspects of regulatory changes and or developments are highlighted (actual or potential)
Maintaining an up to date and traceable consultation tracker to provide an auditable view on the regulatory consultations identified as relevant to our market, our business and our clients (PMO)
Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists
Ability to read, analyze and interpret general business periodicals, professional journals, technical procedures, or governmental regulations
Very strong attention to detail
Excellent communication and team leadership skills with strong managerial skills
Excellent writing, communication, and interpretive skills

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Product Regulatory Affairs Specialist Resume Examples & Samples

Product Stewardship
Product Safety
Classify chemicals per regulatory requirements
Assist with development of standard operating procedures and work rules
Assist with continuous process improvement for safety data sheet authoring process
5 years of relevant experience required
Familiarity with SDS authority software, WERCs
Familiarity with consumer goods manufacturing processes and safety issues
Strong undergraduate coursework in Chemistry, including Inorganic Chemistry, Organic Chemistry and Calculus
Product Stewardship and Product Safety professional experience
Willing to accommodate local travel to meet with clients
Masters degree preferred
Previous employment with or involving a consumer goods manufacturing company (i.e. pharmaceuticals, household items, cosmetics & personal care companies)
Familiarity with GHS / Purple Book / OSHA HCS a plus
Ability to apply rules to derive chemical classifications
Experience with consumer goods and/or personal care manufacturing preferred
Experience with the pharmaceutical experience preferred

Principal Regulatory Affairs Specialist Resume Examples & Samples

Plan and coordinate manager and wider team meetings, including agenda and presentations
Support inputs for quarterly management and functional review meetings
Act as a central point for regulatory changes within the region as well as appropriate communication to the business
Act as delegate for the Director of Regulatory Affairs as required
Act as supporting resource in regulatory activities associated with business initiatives including coordination with outside consultants
Developing working knowledge of associated business initiative regulations and act as a voice for regulatory requirements on a project by project basis
Support the region in relation to advocacy activities and work with SMEs to lobby change in areas impacting the business
Establish and maintain good working relationship with regional RA peers and local business units to gain positive and timely support
Serve as regulatory consultant to marketing and government teams as required
Complete the mandatory Quality training subject to the defined timeline and ensure compliance with internal quality system and policy
Supports Director of Regulatory Affairs to carry out responsibilities for the region as required
A seasoned, experienced regulatory professional with medical devices and associated regulatory experience (5+ yrs minimum)
Solid understanding of EU medical device regulations
Experience of environmental regulations would be advantageous
Demonstrates a working knowledge of EU and European wide advocacy, including revised Medical Device Regulation

Associate Regulatory Affairs Specialist Resume Examples & Samples

Assists in Supplier Quality activities, with focus on obtaining Supplier ingredient documentation related to but not limited to Country of Origin, Allergens, Kosher, Halal, Organic, and Non GMO
Product registrations where applicable
Reviews Foodservice/Chain product related artwork routed through Blue
Assists in special projects related to LW Foodservice/Chain labels and packaging
Assists in the shipping and handling of nutrition samples as well as the maintenance of the RA /Nutrition SharePoint site with the incoming nutrition data
Assists in the maintenance of the ESHA/Genesis software database
Assists with other RA/Nutrition projects in a coordinated, prioritized and timely manner
Must be able to sit for periods of time, up to 4 hours
Must be able to drive a company or rental vehicle for up to 8-10 hours or 300 – 500 miles

Principal Regulatory Affairs Specialist Resume Examples & Samples

Plan & execute global regulatory activities necessary to obtain and maintain regulatory clearances/approvals within the domestic and International markets. In this role, you will ensure compliance with relevant FDA, MDD, ISO and other global regulations for Sciex’s products
You will lead FDA pre-submission meetings, IDE’s, develop FDA regulatory strategies, author 510(k) submissions, and negotiate requirements/questions needed to gain FDA 510(k) clearance
Provide regulatory guidance for product development and planning throughout the product lifecycle
Active participation on internal development teams (core teams), providing US and/or International regulatory strategy and execution. Identify needs for bench, animal, and clinical testing
Provide regulatory review of labeling and advertising, design changes, and specification changes
Assist in keeping company informed of regulatory requirements in the US
Prepare regulatory filings such as 510(k), IDE, Pre-Submission meetings, Design Dossier, Notified Body submissions and subsequent revisions/supplements and amendments by managing all associated deliverables and timelines
Identify need for new regulatory policies, processes and SOPs. Drives the execution of said documents
Monitor and submit applicable reports and responses to regulatory authorities
Maintain annual licenses, registrations and listings
Ensure compliance with product post-marketing approval requirements
Review and approve required reports, supplemental submissions and other post marketing commitments
Evaluate post-market incident reports and determine MDR requirements. Report adverse events to internal stakeholders
Prepare and facilitate collection of necessary information for post-market health hazard evaluations, recall evaluations, MDR evaluations
Provide regulatory input for UDI compliance requirements
Minimum Education - Bachelor's degree in science (biology; chemistry; microbiology; immunology; medical technology; pharmacy; pharmacology); math; engineering; or medical fields is preferred
Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)
510(k), IDE or PMA experience
Strong communications skills
Strong technical writing skills
Minimum Experience / Training Required
7+ years of experience preferred
LI-JM1

Associate Regulatory Affairs Specialist Resume Examples & Samples

1 year regulatory/clinical experience at a medical device company or 1+ year(s) related experience and training
Microsoft applications, which includes working with templates, and editing and formatting complex documents
Competency with various software packages: (Word, PowerPoint, Visio, Excel, Access, Internet, HTML code)
Working knowledge and/or experience working in SAP or other related system
Experience with Documentum, Agile or other document management systems used in the medical device/pharmaceutical industry
Advanced knowledge level of Microsoft applications, which includes creating templates, editing and formatting complex documents in Word, PowerPoint, Visio, Excel, and Access
Experience with Internet/Intranet technology and interactive software applications
Flexible with priorities and responsibilities
Effective organizational skills and attention to detail
Regulatory or Quality department experience
Works well under pressure in a dynamic environment
General knowledge of industry practices, techniques and standards

Senior Regulatory Affairs Specialist Patient Care Resume Examples & Samples

B.S. or B.A. degree required. MS or MBA preferred
Minimum 5+ years of Regulatory Affairs experience required
Minimum of 3+ years of experience in the medical device industry. Combination product experience preferred
Must have experience with US and European medical device submissions, regulations, and standards
Must have directly authored 510(k)s and have experience in preparing other regulatory documents (i.e. EU Technical File or Design Dossier)
Must have experience interacting with FDA and/or other regulatory agencies
Must have a solid understanding of manufacturing and change control, and an awareness of regulatory trends
Must possess strong technical writing skills and analytical ability
Must possess strong communication skills and ability to work collaboratively in a team environment

Principal Regulatory Affairs Specialist, NDT Resume Examples & Samples

Master’s Degree or Doctorate in Regulatory Affairs, Engineering, Quality or related technical field
Experience in developing regulatory strategies and preparing regulatory submissions (domestic and international) for Class II and Class III (FDA classification scheme) medical devices
Experience in IDEs, PMAs, 510(k)s, Amendments, Supplements, Annual Reports, 30 day Notices, Real Time Reviews, 180 Days, Design Dossiers, Technical Files and Notification to Notified Bodies
Product experience with Radio Frequency (RF), Electromagnetic Compatibility (EMC), Software and Implantable devices and thorough knowledge of regulatory requirements
Experience with regulatory support of clinical trials
Have detailed knowledge of international medical device regulatory requirements
Must be able to assemble facts from various areas, analyze data, and provide informed recommendations to management
Works well under pressure in a dynamic timeline-driven environment

Senior Regulatory Affairs Specialist Resume Examples & Samples

B.S. or B.A. degree required. MS or MBA preferred
5+ years of Regulatory Affairs experience
3 years of experience in the medical device industry
Must have authored 510(k)s
Must have knowledge of US, European/International regulations and standards
Experience in preparing regulatory submissions
Experience interacting with FDA and/or other regulatory agencies
Must work well in team environments
Must demonstrate leadership skills in team setting
Proven analytical abilities; Solid understanding of manufacturing and change control, and an awareness of regulatory trends

Principal Regulatory Affairs Specialist Resume Examples & Samples

9 - 13 years of experience within medical device industry in a regulatory and/or quality function. Cross-functional experience preferred
Demonstrated ability to provide guidance and mentoring to less experienced colleagues and cross-functional team members. Viewed as an expert in regulatory matters
Expert knowledge of medical device regulations with an emphasis on FDA and MDD. Experience with additional international regulations preferred
Extensive 510(k), IDE, PMA, EU MDD 93/42/EEC Technical File/Design Dossier (original/revision/supplements) preparation, review, and submission experience
Extensive experience interacting directly with FDA, EU, Japanese PMDA, and other regulatory bodies' reviewers/inspectors
Experience representing the company/industry as an active member of AdvaMed, OSMA, etc
Demonstrated understanding of the FDA device listing and establishment registration process
Demonstrated ability to work effectively in a team based environment
Demonstrated excellent interpersonal, written, oral, communication, organizational and planning skills
Demonstrated knowledge of MS office suite (Word, PowerPoint, Excel and Access)
Excellent understanding of scientific principles
Serve as RA expert and make autonomous decisions on complex product development teams to ensure US, EU, and other international regulatory requirements are incorporated as part of the development process
Serve as a divisional expert on regulatory matters and provide guidance and mentoring to less experienced colleagues and cross-functional team members
Evaluate medical device regulations and develop strategies for bringing products to market
Remain informed regarding new regulations or changes to existing regulations and communicate pertinent information to project teams and RA management
Provide expert review of FDA submissions, design dossiers, technical files, and other regulatory documents
Author FDA submissions, design dossiers, and other regulatory documents to obtain approval to bring new or modified products to market
Develop EU technical files to meet the requirements of MDD93/42EEC and support granting the CE mark
Interface and coordinate directly with FDA, notified body reviewers, and other regulatory agencies on submissions approvals or other issues
Ensure project team(s) and RA management remain informed regarding all regulatory agency/notified body correspondence
Author post market submissions (progress reports, annual reports etc.)
Review labeling and marketing literature for compliance to regulatory requirements
Review Quality System procedures for regulatory impact
Prepare and update US product listings
Support Marketing, R&D and Manufacturing teams with regulatory assessments of proposed changes or product transfers
Review and approve change documentation while considering US, EU and other international regulatory requirements
Represent the company/industry as an active member of AdvaMed, OSMA, etc
Provide regulatory support for audits
Lead the development, implementation, and maintenance of regulatory procedures to ensure ongoing compliance of new and existing products
Ensure that all regulatory information systems remain accurate and readily accessible. Lead changes to the systems where required
Lead divisional improvement activities and transactional LEAN projects

Quality Assurance & Regulatory Affairs Specialist Resume Examples & Samples

Manage and establish / maintain compliance with FDA QSRs (GMP) including company registration, new product submissions, establishing FDA communication/channels for compliance on medical device listings/classifications, management of CAPA system
Responsible for the Documentation Control Process, and Engineering Change Control Process
Establish / maintain compliance with the EU IVD directive and other international regulations and standards as required, including registrations
Maintain Technical Documentation files in compliance with international requirements
Responsible for working with R&D and Manufacturing to develop validation protocols for production processes and generating the final report, covering the validation results and a recommendation for approval or disapproval for the release of the process to Manufacturing
Ensure compliance of labeling and advertising for all products in a regulated class
Support the QMS training program, including applicable QMS and regulatory requirements, and act as a resource to ensure quality and regulatory compliance
Monitor and trend key quality objectives and present data to Senior Management during management review meetings
Conduct internal audits and ensure closing of findings
Responsible for supporting Management Review with metrics data on change requests and Quality Documents and supporting timely document search and delivery during audits
Travel up to 25% is required
5+ years of experience in Quality Assurance and Regulatory Affairs for Medical Devices
Experience in scheduling and performing internal audits and auditing vendor quality systems, writing standard operating procedures and work instructions, developing and Implementing Management Control Systems, and maintaining CAPA system
Experience with Canadian ISO 13485 and all international market medical device requirements is a plus
Good working knowledge of Microsoft Office software
Excellent communication and interpersonal skills with a customer-oriented focus
Strong ability to handle multiple priorities simultaneously
Meticulous attention to detail and accuracy and the ability to clarify areas of ambiguity
Ability to be a self-motivated multi-tasker and ability to work in a team environment

Senior Regulatory Affairs Specialist Resume Examples & Samples

Provide assistance in organizing and maintaining key functions for regulatory affairs
Coordinate the review and assemble regulatory submissions (NDAs, INDs), amendments and post-approval supplements including review and evaluation of supporting documentation for accuracy and conformance with the applicable ICH and FDA regulations and guidances
Work closely with the manager, Regulatory Affairs to compile and review annual reports, drug history and establishment registrations to ensure accuracy and completeness prior to submission to FDA
Assess the change control proposals/packages to determine the appropriate regulatory mechanism and appropriate documentation for submission to regulatory agencies
Coordinate submission of responses to Health Authority inquiries and regulatory submissions
Provide regulatory support for the review and approval of labeling
Assist in the preparation and review of departmental SOPs on an ongoing basis
Maintain department tracking/control systems and monitor them for improvement
Perform other duties as assigned or approved by the Group Head Regulatory Affairs
Good working knowledge of drug approval process; experience with drugs and medical device submissions preferred
Strong organizational and project management capabilities required; effective oral and written communications skills required

Associate / Regulatory Affairs Specialist Resume Examples & Samples

Prepare and submit applications to the FDA for clinical testing and marketing of new/modified medical devices (e.g., 510(k)’s, IDE’s, PMA’s, PMA supplemental applications)
Support in determination of the appropriate regulatory submission requirements and strategies for new or modified products. Prepare required documentation as needed (e.g., No 510(k) Rationales, international change notifications)
Coordinate review of FDA submissions and test protocols with Corporate Regulatory, Medical and Legal Departments, and respond to any questions posed by these departments or the FDA
Prepare application documentation for international marketing approvals (i.e. CE Mark Technical files and Dossiers, JSTED, International Dossier)
Assist Product Development and Quality Assurance in planning pre-clinical studies and bench testing that will ultimately be used in regulatory submissions
Assist in the review of proposals for clinical design validations, clinical field trials and customer preference tests
Represent regulatory affairs on product development teams to provide direction with respect to regulatory/clinical requirements and strategy
Assist in development of new product instructions for use/promotional material. Review product labeling for compliance with medical device regulations and Division/Corporate Policies
Provide marketed product regulatory support for change management activities, product registrations, and business improvement activities
Support due diligence and business integration activities as assigned
Support the development and implementation of Davol and Bard regulatory processes, procedures, and standards as assigned
Bachelors of Science required, with emphasis on life science or engineering
Associate RA Specialist: Minimum of 0 to 3 years knowledge and experience with regulatory requirements for medical devices (IDE’s, PMA’s, 510(k)’s, CE mark technical files and design dossiers)
RA Specialist: Minimum of 3 years knowledge and experience with regulatory requirements for medical devices (IDE’s, PMA’s, 510(k)’s, CE mark technical files and design dossiers)
Previous experience in supporting regulatory projects and R&D/Quality teams
Solid knowledge in FDA, EU regulations for medical device
Good oral and written communications skills and ability to work on cross-functional teams
Working knowledge of statistics and electronic documentation and information systems
Professional certifications preferred
Advanced Degrees preferred

Senior Regulatory Affairs Specialist Resume Examples & Samples

Assist in SOP development and review
Provide regulatory input to product lifecycle planning
Continue to revisit and compare regulatory outcomes with initial product concepts to make recommendations on future actions
Assist in the development of regional regulatory strategy and update strategy based upon regulatory changes
Understand; investigate and evaluate regulatory history/background of class; disease/ therapeutic/diagnostic context in order to assess regulatory implications for approval
Determine trade issues to anticipate regulatory obstacles
Determine and communicate submission and approval requirements
Participate in risk-benefit analysis for regulatory compliance
Assess the acceptability of quality; preclinical and clinical documentation for submission filing
Compile; prepare; review and submit regulatory submission to authorities
Monitor impact of changing regulations on submission strategies
Monitor applications under regulatory review
Monitor and submit applicable reports to regulatory authorities
Evaluate proposed preclinical; clinical and manufacturing changes for regulatory filing strategies
Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval
Maintain annual licenses; registrations; listings and patent information
Assist compliance with product post marketing approval requirements
Review and approve advertising and promotional items to ensure regulatory compliance
Assess external communications relative to regulations
Review regulatory aspects of contracts
Assist with label development and review for compliance before release
Submit and review change controls to determine the level of change and consequent submission requirements
Analyze the input of cumulative product changes to current product submissions
Contribute to the development and functioning of the crisis/ issue management program
Ensure product safety issues and product-associated events are reported to regulatory agencies
Provide regulatory input for product recalls and recall communications
2-3 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area. 3-4 years’ experience in a regulated industry (e.g., medical products, nutritionals)

Senior Regulatory Affairs Specialist Resume Examples & Samples

Medical writing
Advertising and promotion
Labeling
Controlled substances (e.g. DEA)
Restricted substances (e.g. REACH)
Compendial / standards
Import / export
Country specific regulatory support
Regulatory history, guidelines, policies, standards, practices, requirements and precedents
Regulatory agency structure, processes and key personnel
Principles and requirements of applicable product laws
Submission/registration types and requirements
GxPs (GCPs, GLPs, GMPs)
Principles and requirements of promotion, advertising and labeling
International treaties and regional, national, local and territorial trade requirements, agreements and considerations
Domestic and international regulatory guidelines, policies and regulations
Ethical guidelines of the regulatory profession, clinical research and regulatory process
Communicate effectively verbally and in writing
Communicate with diverse audiences and personnel
Write and edit technical documents
Work with cross-functional teams
Work with people from various disciplines and cultures
Negotiate internally and externally with regulatory agencies
Pay strong attention to detail
Manage projects
Create project plans and timelines
Think analytically
Organize and track complex information
Exercise judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results
Has broad knowledge of various technical alternatives and their potential impact on the business
Exercise good and ethical judgment within policy and regulations
Use in-depth knowledge of business functions and cross group dependencies/ relationships
Define regulatory strategy with supervision
Follow scientific arguments, identify regulatory scientific data needs and with supervision solve regulatory issues

Regulatory Affairs Specialist Resume Examples & Samples

Contribute to local Innovation and Renovation (I&R) projects and support Canadian market launches
Ensure regulatory compliance of formulations, raw materials and finished products, labelling and any brand communication to consumers and healthcare professionals by working in close collaboration with Marketing, Medical Affairs, Technical Application Group, Quality, Legal, US and global counterparts
Approve all product related claims and coordinate substantiation dossiers where required. Provide regulatory support and guidance to local and global internal networks
Prepare and coordinate regulatory submissions for licensing and health authority engagement; prepare responses to health authority requests and apply valid scientific rationale to facilitate regulatory approvals and positive assessments. Keep the business informed of submission status and outcome
Keep abreast of the Canadian regulatory environment and significant international developments from health agencies (such as the US FDA), scientific authorities (such as IOM and EFSA), and international standard setting organizations, sharing this regulatory knowledge internally
Propose and implement validated action plans in response to external regulatory changes and from Nestlé’s global initiatives
Participate in industry working groups and discussions with local authorities on specific issues
University degree in Science or related discipline is required. An advanced degree or post-graduate Diploma or Certificate from a Regulatory Affairs program are assets
Minimum 3 years of experience in Regulatory Affairs in regulated health products, food and beverage or CPG regulations. Familiarity with the Food and Drugs Act and Food and Drugs Regulations is essential
Applied knowledge in at least one of the regulatory topics of NHPs (highly preferred), Foods for Special Dietary Use or Infant Formula (highly preferred), supplemented or fortified foods, self-care products or a product category involving regulatory submissions
Knowledge and experience in nutritional science, product formulations (raw materials through finished products) and advertising standards in a scientific and regulatory context
Exceptional organizational & efficiency skills – ability to organize work, multi-task, create detailed plans, monitor progress, follow-up and meet deadlines
Excellent oral and written communication and interpersonal skills
Demonstrates initiative and is proactive; ability to work independently, anticipate needs and be forward- thinking
Advanced Microsoft Office skills, including Outlook, Excel, Word and PowerPoint
Bilingualism (English & French) is an asset

Senior Regulatory Affairs Specialist Resume Examples & Samples

Provides strategic and technical leadership in assigned areas
Represent ConAgra’s interests in external forums in areas of assigned responsibility
Implements and provides ongoing management for processes and procedures within assigned technical area(s) of responsibility
Provides day-to-day technical support to ConAgra partners in Supplier Quality, Procurement, Platform Quality, and Enterprise Food Protection & Regulatory Affairs associated with assigned areas
Develops technical evaluations and analysis of data in managing situations and issues relative to assigned areas
Provides technical expertise to Escalated Incidents and Special Situation (EISS) program and provides oversight to corrective actions
Evaluates effectiveness and assures continuous improvement in assigned areas of responsibility
Collaborates with other departments to develop and implement policies and procedures, and training for topics in area of assigned responsibility within corporate and plants
Office

Principal Regulatory Affairs Specialist Resume Examples & Samples

Works with Regulatory Affairs Management to determine effective regulatory pathways for a variety of issues
Participates in cross-functional teams to implement the regulatory strategies for the timely support of project team goals
Ensures that product development projects and changes to existing products are conducted in compliance with the appropriate regulations
Participates in document review process by reviewing documents for regulatory compliance
Prepares FDA submissions, which may include: 510(k)s, IDEs, IDE Supplements, PMAs, PMA Supplements
Prepares Canadian medical device submissions
Prepares technical files/design dossiers for European CE mark
Interacts with regulatory bodies
Reviews and approves promotional material to assure compliance to Regulatory requirements
Complies with all Quality System requirements
Reviews technical publications, articles and abstracts to stay abreast of regulatory developments in the industry
May include other duties as defined by the Regulatory Affairs Manager
Excellent writing skills with ability to write detailed information for submissions
Excellent ability to read, analyze and interpret technical documents, professional journals, technical procedures and government regulations
Strong verbal skills including presentation skills
Strong interpersonal skills including the ability to interact with all levels of the company
Strong computer skills including Microsoft Office
Excellent working knowledge of medical device regulations (21CFR) and FDA law
Solid working knowledge of the regulatory requirements related to European medical device directives
Capacity to communicate regulations to technical functions within the company
Ability to manage relationships with FDA
Experience with document control systems such as Agile and Oracle
Medical device software submission and validation experience highly desirable
Minimum of 7+ years’ experience in an FDA regulated industry preparing regulatory submissions for medical devices

Regulatory Affairs Specialist Resume Examples & Samples

Bachelor's Degree in Pharmacy or Life Science
2-3 years regulatory experience, or combination of higher education/less experience
Or substitution of equivalent relevant work experience
Broad regulatory affairs experience
Good interpersonal skills
Good knowledge Global Regulatory Affairs Procedures
Proven ability to work effectively in a team
A good knowledge of a number of country specific clinical trial application procedures Expert knowledge of ICH and global regulatory guidelines
Familiar with computers and their applications
Good organizational and planning skills
Must be able to work autonomously with minimal supervision
Planning skills
Mental skills required in areas of reading and interpretation of data, numeracy, language, analytical, investigative, verbal and written communication, customer contact, attention to detail, multiple project tasking

Principal Regulatory Affairs Specialist Resume Examples & Samples

8 years of experience, preferably in the medical device industry or related field experience (e.g., hospital / clinical setting, laboratory setting)
BA/BS in a Life or Physical Science or equivalent
Ability to develop and maintain excellent working relationships with regulatory agencies / bodies
Microsoft Office
Knowledge of U.S. and European medical device regulations
Information Mapping

Principal Regulatory Affairs Specialist Resume Examples & Samples

7+ years industry experience in applicable domestic / International submissions, design control systems and/or regulatory compliance
4+ years experience with medical device regulatory submissions
Candidate must have a working knowledge of FDA, ISO, QSR, and EU regulations for handling complaints, reporting incidents, and implementing corrective and preventive actions
Experience in due-diligence evaluations of companies and/or product acquisitions
Experience in marketing materials review and the maintenance of compliant commercialization strategies
Experience in electromedical devices
Experience with biocompatibility testing and sterilization validation preferred
Experience with international medical device consensus standards preferred
Good presentation skills
Must be able to handle multiple tasks/projects and manage priorities accordingly
Have a high tolerance for ambiguity
Ability to work in a team environment and exert influence without alienating others
Ability to work independently when required with minimal management oversight
Under general supervision, works within established guidelines and has flexibility as to method, priority and timing of job duties. This position requires a significant amount of initiative and judgment
While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to use a computer, and communicate with peers and co-workers

Principal Regulatory Affairs Specialist Resume Examples & Samples

Bachelor's degree in science, engineering, healthcare or related field
7+ years of US and International medical device regulatory submission/approval experience, to include FDA, MDD, MHLW, and TGA
Knowledge of FDA, EU, MHLW, and TGA requirements
Demonstrated experience in preparing PMA or 510(k) submissions for FDA, and Technical Files for EU
Demonstrated experience in global regulatory strategy and execution
Strong communication and negotiation skills with global regulatory bodies
Excellent written and oral communication skills
Proficiency in MS Word, Excel, and PowerPoint
Excellent organizational and multi-project management skills and attention to detail
Experience with Class III devices desirable

Principal Regulatory Affairs Specialist Resume Examples & Samples

Regulatory Affairs Certification (RAC)
Experience in developing regulatory strategies
Able to assess changes to design, process, labeling, packaging, sterilization and software to products in the market and under development for Regulatory reporting
Good working knowledge of FDA and international regulatory agency requirements, ISO/GHTF standards
Must be able to write clear, understandable technical documents, i.e. regulatory documentation or scientific presentations. Ability to compile data and summarize results
Technically savvy; must be able to discuss, understand and make decisions regarding a wide array of engineering disciplines and complex technical/logistical issues
Organized, efficient, process-oriented; high attention to detail
Effective interpersonal/communication skills
Ability to effectively manage multiple projects and priorities
Demonstrated Microsoft Word, Excel, Office, PowerPoint, and Adobe software skills

Senior Regulatory Affairs Specialist Resume Examples & Samples

Typically responsible for two or more of the following duties
Research and analyze applicable laws and regulations; develop and implement the necessary policies and procedures to ensure the Company’s ongoing compliance with Federal, State and local requirements
Implement systems and processes needed to ensure compliance with the receipt, storage and distribution of medical devices
Conduct periodic audits on facilities and customer site visits to assess levels of compliance and risk
Monitor compliance with DOT requirements for the classification, storage and distribution of Hazardous Materials; as well as the activities to comply with environmental laws, including the registration and disposal of pesticides and other type of type of chemical products
Coordinate the implementation of systems and procedures to ensure compliance with OSHA regulations
Support Distribution Center management and designated staff on the actions necessary to maintain regulatory compliance
Provide support during government inspections and formulating the appropriate response and corrective actions
Develop appropriate awareness and training programs for TSMs consistent with regulatory compliance policies and procedures
Conduct routine Regulatory audits of Henry Schein facilities, affiliates and subsidiaries
Conduct Quality Assurance Audits as scheduled and ensure the effective and timely facilitation of suppliers and internal quality audits and follow-up on CAPAs/observations
Stay current with new or potential business opportunities and prepare for all QA Activities
Research applicable FDA, ISO standards to ensure the company’s ongoing compliance with the U.S. and International Regulatory requirements (Medical Devices Directives and FDA QS Requirements)
Approve packaging/labels for all private label products to assure compliance with regulatory requirements
Participate in special projects and perform other duties as required
Professional skills with an understanding of industry practices and company policies and procedures
Developing proficiency with tools, systems, and procedures
Good planning/ organizational skills and techniques
Developing problem solving skills
Good writing and communication skills
Excellent conflict resolution skills
Good decision making skills
Excellent interpersonal skills
Exercise judgment within defined procedures and practices to determine appropriate action
Direction from manager/director is needed on some issues
SPECIFIC KNOWLEDGE & SKILLS
Thorough understanding of regulations applicable to HS operations
General Knowledge of ISO 9000

Principal Regulatory Affairs Specialist Resume Examples & Samples

Maintain current knowledge of the developments and changes to applicable laws, regulations and industry standards
Provides technical guidance and regulatory training/mentoring to other Regulatory Affairs employees and cross-functional teams
Provide support for acquisitions, including due diligence and post-acquisition assessment and education
Provide support for internal and Regulatory Agency audits

Regulatory Affairs Specialist Resume Examples & Samples

Management of new product development and registration projects and for conducting routine regularoty operations to ensure compliance
Provide regulatory support to conduct research trials for new products or label extensions for existing products
Assisting R&D and New Product Development Manager as a team member when required product development
Provide re-registrations and return/reports for products and ensure that MSD products comply with the regulatory and legal requirements set by the local regulatory authorities
Ensure all advertising, promotional and educational/technical materials that are related to products marketed comply with applicable local laws and regulations and consistent with all corporate and MSD Animal Health’s policies and standards, and reflects MSD’s Code of Conduct
Support product registrations as required and provide technical support to internal/external customers

Regulatory Affairs Specialist Resume Examples & Samples

Maintain knowledge of FDA Drug and Medical Device submission requirements. Prepare regulatory submissions assuring that submissions are accurate, submitted on time, and gain approvals as scheduled
Specific ability to file New drug applications (NDA) with clinical investigation requirements and abbreviated new drug applications (ANDA)
Specific ability to file drug master files for active pharmaceutical ingredients
Files supplements and annual reports as required for all active drug and medical device approved and pending applications
Evaluates new product proposals presented by customers to assure that the product can be produced in a regulatory compliant manner
Maintain organization of regulatory files to assure accurate responses to agency requests and maintenance of medical device design history files
Maintain expertise regarding current and developing U.S. and international food, drug, and medical device standards and regulations and how they impact Airgas’s business and quality system
Assist in assuring and sustaining compliance with all regulatory requirements associated with medical products and processes
Coordinates departmental filing activities for all electronic and paper records associated with FDA and similar activities
Review and approve validation protocols and final reports
Provide compliance audit and Annual Product Review feedback to business entity leadership
Monitor performance against Quality standards and champion suggestions for continuous improvement
A Bachelor Degree in Engineering or Life Sciences required
5+ years experience researching, interpreting and maintaining regulatory filings with drug, device and food (FDA) regulations
Demonstrated success in management of significant projects in diverse organizations
Knowledge of local, state and federal laws pertaining to production of drugs and medical devices
Experience resolving regulatory issues in collaboration with agencies and public interest groups
Ability to work on global special projects where multiple interests intersect
Extremely organized and effective at time management
Excellent communication and team leadership skills with strong managerial skills
Advanced knowledge of Microsoft Office applications (Word, Excel, PowerPoint, and Outlook)
Ability to read, analyze and interpret general business periodicals, professional journals, technical procedures, or governmental regulations
Ability to write routine business reports and business correspondence in English
Ability to effectively present information and respond to questions from employees and/or customers
Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists
Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals using the English language
Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals
Ability to compute rate, ratio, and percentages

Principal Regulatory Affairs Specialist Resume Examples & Samples

Bachelor Degree in relevant field
7+ years with Bachelor Degree medical device experience, and work experience in regulatory affairs
5+years with Master’s Degree medical device experience, and work experience in regulatory affairs
Experience in the preparation of 510(k) submissions, EU technical files and dossiers
10+ years with Bachelor Degree medical device experience, and work experience in regulatory affairs
8+years with Master’s Degree medical device experience, and work experience in regulatory affairs
In-depth knowledge of U.S. and EU regulations and a working knowledge of key industry standards applicable to a medical device manufacturer, with functional understanding of international device regulations
Direct experience in radiation health regulations
Knowledge of Good Manufacturing Practices
Basic office computer skills (email, word-processing and spreadsheet software)
Must have a high tolerance for ambiguity
Must be able to independently identify and initiate tasks/projects in line with objectives
Ability to provide guidance to lower level personnel without alienation
Regularly addresses complex problem with ingenuity and innovation
Ability to handle multiple tasks/projects and manage priorities accordingly
Ability to lead a team to completion of objectives
Successful track record in working on project teams in a matrix organization environment
Experience in the preparation of PMA’s (pre-market approval) and IDE’s (Investigational Device Exemption) beneficial
Understanding of diagnostic x-ray products and their respective regulations (21 CFR Subchapter J) preferred
Knowledge of international quality and product standards for electro-medical equipment (e.g. ISO14971, ISO13485, EN60601, IEC62304, etc.) preferred
Experience in establishing and implementing world-wide approval strategies for complex capital equipment systems preferred
Experience in due-diligence evaluations of companies and/or product acquisitions preferred

Senior Regulatory Affairs Specialist for Development Innovations Resume Examples & Samples

Working knowledge of current FDA regulations and GCP guidelines regarding regulatory affairs as relating to clinical research
High-level of proficiency with MS Office and Adobe Acrobat
Exceptional attention to detail in a fast-paced environment
Strong organizational and communication skills
Critical thinking and good decision-making skills
Ability to multi-task and meet strict deadlines
3 - 5 years experience in healthcare, research or other science or research related field
3 years’ experience in regulatory affairs or regulatory operations
A degree specific to regulatory affairs or clinical research may be substituted for one year experience in clinical research or regulatory affairs

Principal Regulatory Affairs Specialist Resume Examples & Samples

Analyzes and reports on changes in regulations and their expected impacts
Prepares federal and state certification applications and required filings
Assists management in the monitoring of state and federal regulatory and legislative development to identify issues affecting company's operations and plans
Assists in coordinating the representation of organization's interests before state regulatory and legislative bodies or industry standard setting committees
Influences rules and procedures
Provides guidance to less experienced regulatory affairs analysts
Performs other job-related duties as assigned
High School Grad / GED
Bachelor's - Arts
Experience:7+ years
None

Audit & Regulatory Affairs Specialist Resume Examples & Samples

Assist with coordination of bank-wide regulatory activities, including logistical and administrative support for on-site examinations, coordinating collection/compilation of information requests, scheduling/acquiring necessary resources for examiners (computer access, conference rooms, physical access to buildings, etc.), compiling/drafting letters and other correspondence in response to examination results
Maintain effective working relationships with the regulatory examiners and internal management stakeholders
Assist with internal communication/dissemination of examination schedules, progress reports, and results
Assist with tracking and governance reporting related to regulatory findings and recommendations
Work on Internal Audit departmental and cross-functional projects and internal improvement initiatives, as assigned by the Chief Audit Executive or Manager of Professional Practices
Perform assigned internal audits, risk assessments, and other reviews
Bachelor’s degree in accounting, business, or other related field or equivalent work experience
Three to five years of experience in internal audit, compliance, risk management or regulatory affairs required – banking, financial services, or experience in other highly-regulated industry preferred
Ability to establish and foster effective relationships and collaborate with internal and external stakeholders at all levels
Must have excellent written and verbal communication skills
Strong organizational skills required; ability to manage to deadlines, multi-task, and prioritize considered critical for this role

Senior Regulatory Affairs Specialist Resume Examples & Samples

Prepares, review and completes regulatory submissions for INDs, MAAs, CTAs, NDAs, IDEs, ITAs, DSURs and annual reports including post marketing activities to FDA, Health Canada and other regulatory authorities
Collaborates with sponsor, study start up, clinical and regulatory staff to ensure that all regulatory documents required for site IP approval are collected and reviewed in a timely fashion
Prepares and submits serious adverse events (SAEs) and Safety Reports,Medical Device Report (MDR), Development Safety Update Report (DSUR), Clinical Evaluation Report (CER) Clinical Study Reports (CSR), Unanticipated Adverse Devise Effects Reports (UADEs)
Provides update and communicate with sponsor, project manager, study start up and clinical team to anticipate, identify and resolve issues
Assists Associate Director, Regulatory Affairs, in assuming primary or secondary regulatory responsibility for assigned clinical research projects by providing to the project team regulatory information, guidance, training, support and strategic planning based on applicable regulations and guidances issued by the applicable regulatory agency(ies)
Identifies and interprets regulations, guidelines, and other pertinent information issued by applicable regulatory agencies and other regulatory organizations
Identifies essential regulatory documents required for execution of both domestic and global clinical research studies involving drugs, device and combination products
Reviews protocols, consent forms, reports, scientific documents, publications, and related papers, etc., as appropriate for various clinical research projects to ensure compliance with regulations
Ensures the compilation and maintenance of pertinent documentation (e.g., files) required for regulatory compliance for assigned clinical research projects
Provides regulatory guidance and quality assurance assessments for assigned research projects - domestic and international
Develops training modules and presentations to ensure compliance with applicable regulatory regulations, CFR, FDA/ICH guidelines, GCP, Essential Regulatory Documents and project specifications
Creates SOPs, Work Instructions, and procedures for Regulatory Operations, as needed
Serves as a member of groups, teams, or committees related to regulatory affairs, and quality assurance or other designated Novella activities, as appropriate
Serves as Novella liaison with central IRBs
Serves as a mentor for coworkers and train others on tasks or systems
Performs other related duties as assigned
Working knowledge of and aptitude for activities related to regulatory affairs and quality assurance, both domestic and international
Experience interacting with regulatory agencies is preferred
Ability to understand and communicate regulatory requirements for different therapeutic areas and countries and associated submission pathways
Familiarity with or ability to become familiar with regulatory documents, general contents, organization and the methods of filing and tracking
Familiarity with or ability to become familiar with principles of Good Clinical Practice, Good Laboratory Practice and Good Manufacturing Practice., ISO standards
Extensive knowledge of clinical research; knowledge and familiarity with 21CFR11 and EDC systems
Experience in preparation of audit plans and checklists against applicable standards, execution of audits, and preparation of comprehensive written audit reports
Good interpersonal skills with the ability to communicate effectively, both orally and in writing, with all levels of staff, and with the public
Ability to be detail oriented with background adequate to deal with scientific issues related to technical regulations and SOPs
Ability to read and synthesize technical material and to prepare clear and concise written documents
Computer literate at a level allowing utilization of event tracking programs, data loading and information processing related to regulatory affairs and quality assurance
Ability to travel domestically and international
Very limited physical effort required to perform normal job duties

Regulatory Affairs Specialist Device & Diagnostics Resume Examples & Samples

Assist in developing regulatory strategies for the development and registration of medical devices and in vitro diagnostic kits
Support preparation of complex submissions to gain approvals for clinical research and commercial distribution, such as: IDE, ITA, 510(k), PMA, Design Dossier, Technical File, and Canadian Applications
Manage assembly and submission of applications to regulatory bodies including FDA, Health Canada, and Notified Bodies
Identify and interpret regulations, guidelines, and other pertinent information issued by applicable regulatory agencies and other regulatory organizations
Evaluate documentation for clinical research and pre-market applications such as protocols, reports, scientific documents, labeling, risk documents, biocompatibility, ER checklists, clinical evaluations, etc., as appropriate to ensure compliance with regulations
Primary or secondary regulatory responsibility for assigned projects by providing to the project teams regulatory information, guidance, training, support and strategic planning
Keep abreast of, interpret, and communicate applicable regulatory regulations and statutes with internal departments and ensure Novella compliance
Participate in business development activities to grow Novella business. Assist in new business development activities including, but not limited to, client meetings and proposal preparation/presentation
Perform other related duties as assigned
General working knowledge of activities related to medical device and/or IVD regulatory affairs and quality assurance
Experience in medical devices and/or IVDs that includes preparation of clinical research and pre- market submissions and registrations
Good interpersonal skills with the ability to communicate effectively, both orally and in writing, with all levels of staff, and with the public
Ability to be detail oriented with background adequate to deal with scientific issues related to technical regulations and SOPs
Ability to read and synthesize technical material and to prepare clear and concise written documents
Comprehensive knowledge of Good Clinical Practices (GCP), Good Manufacturing Practices (GMP), Quality Systems Management and Good Laboratory Practices (GLP) requirements
Demonstrated experience in client service in the clinical research business preferred
Demonstrated high energy level
Ability to handle multiple tasks and challenges simultaneously
Demonstrated ability to form strong working relationships across functional boundaries
Excellent written and verbal communication skills
Excellent negotiation skills
Ability to develop and manage timelines
Ability and willingness to travel
Ability to travel internationally
Very limited physical effort required to perform normal job duties

Regulatory Affairs Specialist Resume Examples & Samples

Bachelor’s/Master’s degree in a related field preferred, or 6 or more years of hands-on experience with medical device Regulatory Approvals
Must have personal experience with preparation and submission of successful 510(k) or PMA submissions and International registrations
Minimum of 6-10 years of experience in medical device Regulatory Approvals: US FDA Class II/III, EU MDD, Health Canada, and International registrations
Proficient knowledge of medical device regulations: FDA, MDD, global product approval requirements, and standards that are required for product approval
RAPs RAC preferred
Requires strong written, oral and interpersonal skills to be able to effectively compose agency submissions and interface interdepartmentally
Proficient computer skills in Microsoft Word and Adobe Acrobat
May require 5% travel annually with some international travel possible

Regulatory Affairs Specialist Resume Examples & Samples

Define global strategies and timelines for regulatory submissions for the total product lifecycle for medical and non-medical software products
Participate in cross-functional teams by working closely with product development engineering, marketing, clinical, and quality functions
Identify opportunities to implement process and procedural improvements to drive efficiency within a growing digital health organization
Define regulatory responsibilities within a Scaled Agile Framework (SAFe)
Communicate and interact directly with regulatory bodies and local health agencies such as US FDA to effectively drive submissions to clearance/approval
Provide regulatory guidance to internal product development and IT teams regarding global cybersecurity and software healthcare system requirements
Participate as a ResMed representative on external working groups and industry advocacy associations to influence global regulatory policies
Creatively reconcile global regulatory requirements for both consumer and medical software products
Strategically communicate with global teams to efficiently prioritize and execute regulatory strategies
Be willing to work with a Lean team and wear multiple hats to create smart strategies for regulatory submissions and an expanding Quality Management System

Principal Quality Assurance Regulatory Affairs Specialist Resume Examples & Samples

Bachelor’s Degree in Engineering, Science or other related fields
5+ years’ experience in a QA/RA function in medical device or pharmaceutical industry
Experience with preparation of Technical Files and Design Dossiers in support of CE Marking of new products and maintenance of these documents for existing products
Knowledge of global medical devices and combination product regulations (e.g. EU Medical Device Directives/CE Marking, ISO 13485, ISO 14971, ISO 11608, 21 CFR 820, 21 CFR Part 210/211, 21 CFR Part 4, Canadian MDR, JPAL)
Demonstrated experience with implementing continuous improvements to medical device quality systems
Experience with CE marking of pen injectors, connected devices, mobile medical apps (MMA/SaMD) and infusion pumps
Experience with harmonized standards (e.g. EN ISO 10993, EN 60601, EN ISO 14155) utilized to show presumption of conformity with Essential Requirements of EU MDD
ASQ Quality Certification or Regulatory Affairs Certification (RAC)
Experience with Notified Bodies
Six Sigma Black belt experience
Demonstrated leadership skills and management experience
Demonstrated team player
Self-motivated and ability to work without supervision

Product Regulatory Affairs Specialist Resume Examples & Samples

Lead a team of multiple SDS authors and serve as primary client point of contact for a consumer goods manufacturing company
Classify mixtures and pure substances used in consumer products per regulatory requirements using United Nation’s Purple Book
Author, update, publish, and review Safety Data Sheets (SDSs) per regulatory requirements
Coordinate SDS authoring assignments and progress tracking
Position will be primarily be at the client site in Skillman, NJ. Candidate can expect to spend a couple of days per month at our Newtown, PA office. Must be willing to accommodate this local travel to meet with team members
3+ years of directly relevant experience required
8+ years of total professional / non-academic experience required
Bachelors degree (BS, BA or BE) can have been obtained in a variety of fields to prepare for a career in product stewardship / regulatory affairs such as: Environmental Science, Environmental Engineering, Chemical Engineering, Chemistry, or other, or equivalent additional relevant work experience
Thorough understanding of the United Nation’s Purple Book, OSHA HazCom, and EU CLP regarding classification and safety data sheets (SDSs)
Experience classifying mixtures and pure substances and authoring SDS without relying on software rules
Familiarity with SDS authority software program(s)
Familiarity with consumer goods manufacturing processes and product hazard issues
Strong undergraduate coursework in chemistry, including inorganic chemistry, organic chemistry and calculus
Previous SDS authoring experience for a consumer goods company preferred
Additional experience authoring SDSs for other geographies (e.g., Asia-Pacific, Latin America, Africa) a plus
Previous employment with or involving a consumer goods manufacturing company (i.e., pharmaceuticals, household items, cosmetics & personal care companies) preferred

Regulatory Affairs Specialist Global Clinical Investigations Resume Examples & Samples

Back up activities including item restriction preparation
Assisting CSS Global Clinical Regulations Strategy Manager CSS in various internal and external forums as needed
Ensures certain administrative tasks to support the CSS EMEA Department
Bachelors or Masters degree in an area of science. Clinical study or epidemiology experience preferred (Entry level accepted, 1-3 years regulatory experience preferred)
Good written and oral English communication skills
Good Computer skills: Outlook, Excel, Power Point
Conscientious

Regulatory Affairs Specialist Resume Examples & Samples

Monitoring, analyzing, and reporting relevant regulatory changes and developments impacting our market and our clients
Producing weekly and monthly regulatory reports for both internal EY stakeholders across service lines as well as external committee chairs and boards, ensuring that material aspects of regulatory changes and or developments are highlighted (actual or potential)
Proactively managing and maintaining our Stakeholder Engagement plan by organizing meetings for our EY executives, preparing briefing notes and presentations
Coordinating and delivering key Regulatory & Public Policy external events from inception to execution
Maintaining an up to date and traceable consultation tracker to provide an auditable view on the regulatory consultations identified as relevant to our market, our business and our clients (PMO)
Leading on the development of our external R&PP website
Previous Regulatory Analyst experience in the UK market
Ability to apply an analytical and systematic approach to work
Ability to distil complex regulatory issues into simple messages, clearly articulating the ‘so what&#8217
Time and project management skills – able to plan and manage time effectively and flex up and down to deal with key priorities
Ability to interact well with people at all levels within the firm
Excellent oral and written communication skills

Regulatory Affairs Specialist Resume Examples & Samples

Bachelor or Master’s degree in chemistry or life science or relevant discipline
1 - 3 years of experience in a regulatory affairs function in the biopharmaceutical industry
Knowledge of FDA/ICH/EU regulatory affairs requirements and guidelines
Ability to work on multiple tasks to meet company requirements
Demonstrate ability to coordinate and work effectively with cross-functional teams
Experience with using an electronic document management system
Excellent writing, communication, and interpretive skills
Very strong attention to detail
Ability to problem-solve independently
Ability to manage multiple and diverse issues
Good organizational and time management skills; ability to adhere to timelines

Senior Regulatory Affairs Specialist Resume Examples & Samples

Knowledge of Local & International Regulation and Processes
Analytical capability
Prioritizes work to meet deadlines
Communicates clearly, succinctly and effectively
Planning and Organizing skills
Understands the importance of the adherence to compliance
Solid interpersonal skills including the ability to remain calm, professional, diplomatic, and positive
Must have 3-4 years experience at least working in Regulatory Environment (and/or training or equivalent combination of education and experience), preparing submissions for complex devices and a successful track record. Desirable experience in Medical Devices, Pharma background is acceptable

Temporary Regulatory Affairs Specialist Resume Examples & Samples

Perform impact assessments for integration changes and communicate with Integration Contractors at the Business Site
Communicate with suppliers and request legalized documentation
Request updated Free Sales Certificates
Perform local integration change re-registrations, or liaise with local RA contact for that purpose
Support the handling and coordination of questions/answers from the local authorities
Report the re-registration progress to the Re-registration Roadmap lead
University Degree in life sciences, technical (engineering) or related field
Experience in medical device EU CE-marking regulations and international regulations is preferred
Knowledge in medical devices regulations and regulatory topics
Good computer skills, including Microsoft Office Suite
Fluency in English both verbal and written

Principal Regulatory Affairs Specialist Resume Examples & Samples

Professional certification(s) preferred
Demonstrated success in management of regulatory submissions activities
Thorough understanding of global regulations
Strong technical knowledge of medical products
Strong technical understanding of relevant procedures, practices, and associated medical terminology
Strong knowledge of clinical trial strategy and study design, and sponsor reporting requirements
Thorough knowledge of product development process and design control
Excellent research and analytical skills
Ability to effectively manage multiple projects
Excellent written and oral communication, technical writing and editing skills
Strong leadership, interpersonal and influencing skills

Product Safety & Regulatory Affairs Specialist Resume Examples & Samples

Maintain working knowledge of relevant regulations and ensure transfer and retention of knowledge
Provide guidance to assure compliance for AkzoNobel raw materials and products
Respond to internal customers and resolve raw material and/or product issues accurately and in a timely fashion
Communicate effectively both internally (other departments) and externally (Customers, regulators, suppliers, trade associations)
Develop a good understanding of customer needs and relevant regulatory topics affecting the business
Be able to translate complex regulatory requirements to practical implications for the business
Establishing the impact on Performance Coatings SMUs of legislative changes and support PSRA team leaders in communicating legal requirements
Contribute to cross functional project teams as required
Producing and updating regulatory roadmaps
Manage small internal projects
Identify and contribute to the development and continuous improvement of standard procedures (eg SOPs, ISO procedures)
Question validity and accuracy of data and seek advice
University Degree or equivalent in Scientific discipline
Good written and verbal English
Good interpersonal skills, working well as part of a team
Data manipulation and analysis
Ability to understand complex information and make informed decisions based on that information
Ability to produce clear and comprehensive reports and make recommendations using the available data
Good literacy and numeracy skills
Up to 3 years relevant experience (desirable)
Background in product regulations, hazard communication and product stewardship (desirable)
Experience of working in an industrial environment (desirable)

Senior Regulatory Affairs Specialist Device & Diagnostics Resume Examples & Samples

Develop regulatory strategies for the development and registration of medical devices and in vitro diagnostic kits
Prepare complex submissions to gain approvals for clinical research and commercial distribution, such as: IDE, ITA, 510(k), PMA, Design Dossier, Technical File, and Canadian Applications
Manages assembly and submission of applications to regulatory bodies including FDA, Health Canada, and Notified Bodies
Identify and interpret regulations, guidelines, and other pertinent information issued by applicable regulatory agencies and other regulatory organizations
Evaluate documentation for clinical research and pre-market applications such as protocols, reports, scientific documents, labeling, risk documents, biocompatibility, ER checklists, clinical evaluations, etc., as appropriate to ensure compliance with regulations
Primary or secondary regulatory responsibility for assigned projects by providing to the project teams regulatory information, guidance, training, support and strategic planning
Keeps abreast of, interprets, and communicates applicable regulatory regulations and statutes with internal departments and ensures Novella compliance
Participates in business development activities to grow Novella business. Participates in new business development activities including, but not limited to, client meetings and proposal preparation/presentation
Perform other related duties as assigned
Extensive working knowledge of activities related to medical device and/or IVD regulatory affairs and quality assurance
Experience in medical devices and/or IVDs that includes preparation of clinical research and pre- market submissions and registrations
Good interpersonal skills with the ability to communicate effectively, both orally and in writing, with all levels of staff, and with the public
Ability to be detail oriented with background adequate to deal with scientific issues related to technical regulations and SOPs
Ability to read and synthesize technical material and to prepare clear and concise written documents
Comprehensive knowledge of Good Clinical Practices (GCP), Good Manufacturing Practices (GMP), Quality Systems Management and Good Laboratory Practices (GLP) requirements
Demonstrated experience in client service in the clinical research business preferred
Demonstrated high energy level
Ability to handle multiple tasks and challenges simultaneously
Demonstrated ability to form strong working relationships across functional boundaries
Excellent written and verbal communication skills
Excellent negotiation skills
Exceptional ability to conceptualize, develop and manage timelines
Ability and willingness to travel
Ability to travel internationally
Very limited physical effort required to perform normal job duties

Regulatory Affairs Specialist Resume Examples & Samples

Recognize, exemplify and adhere to ICON's values which centers on our commitment to People, Clients and Performance
As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs
Travel (approximately 10%) domestic and/or international
To be familiar with and to work in accordance with relevant ICON SOP’s and internal systems, GXP and appropriate regulations and guidelines
Apply scientific principles and maximize compliance to all aspects of regulatory activities undertaken
Undertake all required tasks requested to meet departmental and project goals, as appropriate
Participate in regulatory and/or clinical trial project teams as required
Plan and track designated project activities including financial tracking under supervision
Initiate product research and regulatory intelligence in support of designated regulatory activities, as required, and provide information on regulatory requirements
Prepare and/or write scientific and regulatory documents and communication letters to Regulatory Authorities, either alone or in collaboration with Regulatory Project Lead or Functional Experts under supervision
Prepare and/or write core regulatory submissions to support clinical trials (Clinical Trial Applications (CTA), Investigational new Drugs (IND), or equivalents), either alone or in collaboration with Regulatory Project Lead or Functional Experts under supervision
Prepare and/or write regulatory submissions to support post licensing administration/activities, e.g. preparation of variations to product approval either alone or in collaboration with Regulatory Project Lead or Functional Experts. Support the regulatory assessment of proposed changes under supervision
Prepare and/or write elements of regulatory submissions to support marketing authorization applications in collaboration with Regulatory Project Lead or Functional Experts. Support the regulatory assessment of procedure under supervision
Communicate/liaise with clients, regulatory agencies/competent authorities and/or other regulatory or Functional Experts on designated regulatory activities as required
Peer review, QA and/or checking, as appropriate, of documents prepared by other professionals within GRA/ICON
Keep the relevant Regulatory Project Lead or designee informed of the progress of project activities at all times
Develop and maintain a current awareness of regulatory requirements through publications, seminars and appropriate training courses as deemed necessary
Liaise and work with colleagues from other departments, clients and, Regulatory Authorities as required
Maintain an accurate record of the time associated with each activity
Other duties as assigned
Develop supporting staff skills, encourage growth and provide regular performance feedback
Manage designated regulatory project lead projects in accordance with established timelines, budget, quality standards and/or contractual requirements
Lead and motivate staff in the projects where assigned as regulatory project lead
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions,
Bachelor’s degree or local equivalent, in the sciences or relevant discipline or equivalent experience qualification
A minimum of 2 years’ experience in regulatory affairs or aligned work and in the pharmaceutical or pharmaceutical contract service industry
Strong organizational skills, ability to manage multiple tasks and meticulous attention to detail
Good written and verbal communication skills
Good written and spoken English
Proficient in the use of Microsoft Office
Due to the nature of this position it may be required for the employee to travel. Therefore, dependent on the employee’s location, the employee may be required to possess a valid driver’s license

PH Regulatory Affairs Specialist Resume Examples & Samples

Handles and supervises product registration administration processes
Updates the company on new regulations and procedures
Maintenance of corporate databases
Clinical Trial Application

Principal Regulatory Affairs Specialist Resume Examples & Samples

Teams with Corporate and International Regulatory staffs to provide support for new products and changes to existing products
Works with engineers and technical experts to resolve potential regulatory issues and questions from regulatory agencies
Prepares FDA submissions, Technical Files, Canadian Applications and International Dossiers for new products and product changes
Prepares documentation for Clinical Studies and coordinate and maintain study communications
Reviews significant product and clinical study submissions with management and negotiate submission issues with agency personnel
Provides support to currently-marketed products as necessary by reviewing labeling, promotional materials, and product and documentation changes per policy and procedure
Interact directly with the FDA and/or indirectly with international regulatory agencies on most products/projects at reviewer level; all significant issues will be reviewed with management
Supports regulatory compliance activities, including manufacturing site registration, GMP, Notified Body audit, post market vigilance reporting, product recalls, etc., as needed
Maintains proficiency in worldwide regulatory requirements; establishes and maintains positive relationships with agency personnel
Provides business and product information to international regulatory staffs to enable development of strategies and requirements, and communicate that information to management
Provides feedback and on-going support to product development teams for regulatory issues and questions
Ensures personal understanding of all quality policy/system items that are applicable
Performs other related duties and tasks, as required
Education and experience equivalent to a Bachelor's Degree in the biological, physical, engineering or material science disciplines
Seven years of regulatory experience, with three of those years of pre and post market clinical trials
Must have experience working with the strategic planning and crafting of Class III medical device submissions in the US
Experience working with principal investigators, research coordinators, IRBs and ethics committees is preferred
Demonstrated knowledge of U.S. FDA regulations, the Medical Devices Directive (93/42/EEC) ISO 13485 Quality System Standard and Canadian Medical Device Regulation
Self-motivated, self-directing, strong attention to detail and excellent time management skills
Strong interpersonal skills and the ability to communicate well -- verbally and in writing -- with others
Demonstrated excellent in submission writing and preparation
Demonstrated computer skills preferably spreadsheets, word processing, database, internet research and other applicable software programs

Associate Regulatory Affairs Specialist Resume Examples & Samples

Apply the Regulatory Foundation
Must be a results-oriented team player capable of working in a fast paced environment with changing priorities
Must be a self-starter able to work with minimal supervision, and able to perform under pressure and in ambiguous situations
Must be organized and detail-oriented, with good analytical and decision making skills
Must demonstrate effective verbal and written communications skills

Principal Regulatory Affairs Specialist Resume Examples & Samples

Lead regulatory aspects of the customs, patient-matched and compassionate use programs across Stanmore , UK and Mahwah, NJ teams
Develop EU technical documentation/design dossiers to meet the requirements of MDD93/42EEC and support granting the CE mark
Interface and coordinate directly with FDA, notified body reviewers, and other regulatory agencies on submissions, approvals or other issues
Lead divisional improvement activities and transactional process excellence projects

Global Regulatory Affairs Specialist Resume Examples & Samples

Ability to contribute to the development of effective and results-oriented regulatory strategic plans that are in line with business objectives
Ability to leverage scientific and technical understanding of regulated products to provide input to product lifecycle management and evaluate regulatory impact on products
Understands and has working knowledge of FDA medical device regulations, European Medical Device Directives, and/or other global regulations. International regulatory medical device experience is a plus
Strong decision making skills in ambiguous or unclear situations
Demonstrated attention to detail and organizational skills
Capable of effectively managing multiple projects with shifting priorities
Ability to identify compliance risks and escalate when necessary
Technical system skills (e.g. word processing, spreadsheets, databases, online research)
Bachelor's degree (or country equivalent) in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred. Higher degree/PhD will be an advantage
Five years or greater of experience in medical device regulatory affairs is preferred

Principal Regulatory Affairs Specialist Resume Examples & Samples

Position provides regulatory support for the Smiths Medical site based in St. Paul, Minnesota. Incumbent develop and prepare regulatory submissions, i.e., 510(k) Premarket Notification, PMA, Design Dossier, and CE Technical Files
The Principal Regulatory Affairs Specialist provides the overall regulatory strategy and guidance to project teams and other departments as assigned to ensure achievement of business objectives and government compliance. This individual proactively evaluates existing and emerging regulatory and quality requirements and directs implementation activities to minimize business exposure and guidance for interactions with government officials. This position is responsible for practicing Quality System Manual procedures and complying with its requirements, and carrying out responsibilities as outlined in safety, health and environmental policies
Develop and prepare regulatory plans, submissions; specifically 510(k) Premarket Notification, PMA, IDE, Design Dossier, Technical Files, Australian Technical Files, Canadian Licensing, and Japan submissions. Coordination of staff support for world-wide registrations for global growth and expansion
Review and ensure regulatory compliance of internal operational and project documentation involved in commercial product release for all assigned projects. Prepare, maintain and ensure regulatory documentation supporting engineering activity is filed and readily available, keeping electronic lists, registers and directories up-to-date
Participate as regulatory representative on project teams, communicate regulatory requirements and strategy. Prepare and conduct meetings / teleconferences with external regulatory agencies as assigned. Assist with data entry and analysis as needed, ensuring data quality and validity. Ensure compliance with regulatory requirements at all times
Support the preparation and maintenance of regulatory submissions as directed
510(k) Premarket Notification, PMA, PMA Supplements, PMA Annual Reports, Design Dossier, Technical Files, Australian Technical Files, Canadian Licenses, and Japan submissions
Essential Requirements Checklists, Design Dossiers, Technical Files and Declarations of Conformity for all CE Marked products
Communication with government regulatory agencies and Notified Bodies and serve as regulatory liaison on the project team throughout the product lifecycle
Provide strategic product direction to product teams and cross functional partners to advise on global medical device regulation
Pre-launch checklists for new and existing products to ensure compliance with internal company requirements and compliance with regulatory requirements
Support for requests from Corporate Registrations Team for global growth and expansion
Maintain all regulatory files, both hard and electronic copies, ensuring documentation, registers, directories and lists are complete and up-to-date
Ensure that compliance to standards, pre-clinical and clinical study designs meet regulatory requirements. Review and ensure regulatory compliance of internal operational and project documentation involved in commercial product release for all assigned projects
Review, edit and approve for SMMD label reviews
Review, edit and approve operational engineering documentation (through change control)
Review, edit and approve project documentation as the active regulatory representative on project teams
Support Corporate Registrations Team with Certificate to Foreign Government applications
Participate as Regulatory Representative on project teams
Review, edit and provide internal regulatory approval signature for project documentation as the active regulatory representative on project teams
Monitor project time-lines and assist in coordination of timely regulatory processes, documentation
In collaboration with senior regulatory representative, prepare and communicate project regulatory strategy
Review and ensure regulatory compliance of internal operational and project documentation and all applicable technical standards involved in product development and commercial product release for all assigned projects
Prepare, maintain and ensure regulatory documentation supporting engineering activity is filed and readily available, keeping electronic lists, registers and directories up-to-date
Develop regulatory plans and departmental positioning in collaboration with the Manager and Director of Regulatory Affairs and Design Assurance
Participate as regulatory representative on project teams, communicate regulatory requirements and strategy
Prepare and conduct meetings/teleconferences with external regulatory agencies as directed
Ensure compliance with regulatory requirements at all times
Review of device labeling in all forms and advertising materials for compliance with FDA submissions and applicable regulations; analyze and recommend appropriate changes
This position is required to assure compliance of Company operations to all applicable laws, regulations and standards, good business practices and company documented procedures including but not limited to FDA, Quality Systems Regulations, ISO 13485, ISO 14001,MDD 93/42/EEC and government occupational health and environmental regulations and statutes
Engage others, promote, and participate in Environmental, Health, and Safety initiatives, focusing on continuous improvement
The Manager and/or Director of Regulatory Affairs may assign other duties, i.e., training, documentation, etc
Manage multiple simultaneous global projects with cross functional teams
Mentorship and development of junior regulatory staff and training for cross functional partners
This position is required to assure compliance of Company operations to all applicable laws, regulations and standards, good business practices and company documented procedures (including knowledge of all standards, government occupational health and environmental regulations and statutes related to the site)
Engage others, promote, and participate in Environmental, Health, and Safety initiatives, focusing on continuous improvement. Participate as Regulatory Representative on project teams
Bachelor's degree in Science or Engineering (or related field) from an accredited college or university required. Ten to twelve years direct experience in regulatory affairs in the medical device/drug or biomedical area
RAPS Professional Certification (RAC) required
Excellent technical knowledge of medical products and understanding of relevant procedures, practices, and associated medical terminology
Excellent interpersonal skills to interface with project team members and able to contribute to the overall success of the team
Excellent leadership, interpersonal and influencing skills
Ability to manage multiple projects and proficiency with Microsoft Office and software tools. Ability to manage multiple projects and proficiency with Microsoft Office and software tools
Ability to analytically assimilate regulatory information and updates and effectively convey these principles to appropriate cross functional departments and levels of management
Ability to critically analyze information as it relates to regulatory submissions and clinical protocols
Excellent verbal, written, and presentation communication skills

Senior Regulatory Affairs Specialist Resume Examples & Samples

Directing and managing the delivery of all required start-up, maintenance and regulatory activities for selected studies as determined by either the agreed algorithm or the Sponsor’s (customer’s) requirements
This includes pre-award activities, oversight of the scope of work, budget and resources
Developing and implementing the RSU Management Plan
Ensuring collaboration across RSU, including communication with regions and countries
Assisting with the creation and review of core scientific, technical and administrative documentation
Contributing to the collection, interpretation, analysis and dissemination of accurate regulatory intelligence
Ensuring overall project efficiency and adherence to project timelines and financial goals

Principal Regulatory Affairs Specialist Resume Examples & Samples

Bachelor’s degree with 7 years of work experience or Master’s degree with 5 years of work experience
Experience in a Regulatory function/role
Experience in developing and preparing regulatory submissions (i.e. Premarket Approval (PMA) for Class II and/or Class III medical devices

Senior Quality Assurance & Regulatory Affairs Specialist Resume Examples & Samples

Initiate and carry out QA&RA activities for assigned products throughout the product lifecycle, collaborating with project managers, R&D teams and external agencies as applicable
Monitor, investigate, document and advise on relevant regulatory requirements and standards
Liaise with selected standards agencies, testing labs and regulatory authorities to ensure timely completion of regulatory activities, provision and filing of evidence of compliance, and resolution of compliance issues
Establish standard operating procedures and work instructions as required for QA&RA and cross functional activities; conduct review and approval of those activities and maintain records according to good documentation practices
Review and approve deliverables from other parties, internally and externally
Participate in risk management, vigilance and post-market surveillance for medical device products
Implement and maintain the Ascom Management System within the North American region, including maintenance of the Site Quality Plan
Coordinate, train and support regional staff on quality & regulatory matters
Investigate customer complaints, observations, non-conformities and reported quality and regulatory issues
Initiate and drive cross-functional improvements to increase customer satisfaction, compliance and quality
Maintain effective Document Control procedures in the region, and act as local super user of SharePoint
Plan, prepare, coordinate, host/conduct, report and follow-up regional external and internal quality, audits in accordance with global audit program
Initiate, drive, document, follow up and ensure timely closure of CAPA
Report on quality system effectiveness and requirements to the management team as required including preparing and executing Management Reviews for the region
Bachelor's degree, or equivalent, in Engineering, Science, Healthcare, Business Administration, Political Science or Law, or corresponding academic merits
Five years’ relevant working experience within healthcare, ICT or other technology businesses, whereof two years’ experience of quality assurance, regulatory affairs, R&D, clinical affairs or other regulated activities

Associate Regulatory Affairs Specialist Resume Examples & Samples

Job title: Associate Regulatory Affairs Specialist
Reporting to: Regulatory Affairs Manager
Functional group: Market Access
Ensures compliance with regulatory agency regulations and interpretations
Prepares responses to regulatory agencies' questions and other correspondence
Organizes and maintains reporting schedules for new drug application and investigational new drug
Assists with preparing necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides
Provides solutions to a variety of problems of moderate scope of complexity
Conducts searches of existing files for requested information
Maintains and archives all regulatory documentation
Bachelor Degree or above
Minimum 2 years solid and reputable experience in regulatory affairs
Proficiency in both spoken and written English and Chinese
Essential –
Market Knowledge
Business Relationship
Regulatory Environment
Reimbursement
Important –
Ability to manage multiple projects1700171754W

Principal Regulatory Affairs Specialist Resume Examples & Samples

Demonstrate and deliver on the Regulatory & Scientific Affairs Department (RSA) Strategic Roles
5+ years experience in the food industry, primarily in regulatory affairs, regulatory compliance, nutrition or product development
Must be a results-oriented team player capable of working in a fast paced environment with changing priorities
Must be a self-starter able to work with minimal supervision, and able to perform under pressure and in ambiguous situations
Must be organized and detail-oriented, with strong analytical and decision making skills
Must demonstrate strong verbal and written communications skills, along with strong influencing and negotiation skills, recognized expertise in functional area, and a strong ability to communicate regulatory and technical issues in lay terms
Must demonstrate strong interpersonal and influencing skills, and be able to act in an appropriate role depending on the situation - facilitator, contributor, leader, executor, etc
Must be proficient in Windows-based applications – Word, Excel, PowerPoint, Access (preferred)

Senior Regulatory Affairs Specialist Resume Examples & Samples

Primary responsibilities will be to provide regulatory affairs input requirements to design and development teams
Prepare and/ or review regulatory strategies, risk management files, applicable codes and standards, regulatory aspects of design projects
Conduct risk and usability assessment of new product designs
Prepare information and submittal documentation to support S&N in-country RA teams for product submittals and registration maintenance
Represent Robotics RA on S&N Corporate teams relating to new MDR implementation and OUS UDI implementation
Prepare or aid in preparation of domestic regulatory submittals
Other duties as assigned
10 years’ experience with International, U.S. FDA 510k submittals and IDE submissions
Successful interaction with international regulatory agencies (MHRA, PMDA, TGA, etc.) and FDA reviewers required
Working knowledge of the EU CE marking process including requirements for a MDD/MDR technical file
Working knowledge of ISO 14971 Risk Management principals and ISO 62366, Application of Usability Engineering to Medical Devices
Recent experience in ISO 13485, Medical Device Quality Systems
Strong leadership, interpersonal, communication and organizational skills required
Must possess a high level of critical and strategic thinking skills and be a detail-oriented team player with ability to influence multi-discipline teams and successfully negotiate with regulatory authorities
Knowledge and experience in development of electromechanical medical devices a plus

Associate Regulatory Affairs Specialist Mena Resume Examples & Samples

Prepares and coordinates regulatory/registration submissions
Obtains timely regulatory approvals to meet business objectives
Ensures that submissions meet relevant external and internal requirements
When/where applicable supports distributors to obtain the necessary regulatory approvals and other regulatory requirements
Liaise and ensure effective communication and coordination with all needed stakeholders (SBU, business distributor etc..)
Develops proficiency in any applicable regulatory requirement that applies to our products and ensures new or changed requirements are communicated within the organization
Provides support to tender and importation requests in case of necessary regulatory documentation
Follow up on Quality Requests, as assigned by the Regulatory Affairs Manager
Ensure full alignment in all activities with relevant department process and company SOP (i.e. order releases, documentation, etc.)
Track and report regulatory project status and informational documents appropriately
Maintain submission correspondence files and other regulatory files in a complete and secure manner for regulatory and quality compliance. Ensure that existing approvals and documentation are maintained as per department/company and region requirements
Coordinate, monitor and execute of Regulatory PMS activities including Vigilance reporting and Field Action within the ME region when applicable and as assigned
Work in accordance with Work Instructions, monitor and record related documentation
Provide additional support for the RA department as needed
Ensure Regulatory and Quality compliance for the region through appropriate documentation and filing in respect to RA and Quality regional activities and documents
University degree in Business Administration or Science
Fluency in oral and written English. French is plus
1 - 2 years of administrative experience
Computer literate

Principal Regulatory Affairs Specialist Resume Examples & Samples

Define the regulatory strategy and manage regulatory submission activities for new product development activities and product maintenance for existing approved products
Team with business unit Regulatory Affairs Specialists (RAS) and international regulatory staffs to provide regulatory support for new products/therapies and changes to existing products. Work with RAS, engineers and technical experts to resolve potential regulatory issues and questions from regulatory agencies
Prepare FDA submissions for new products and product changes as required to ensure timely approvals for clinical studies and market release
Provide support to currently-marketed products as necessary. This includes reviewing labeling, promotional material, product changes and documentation for changes requiring government approval. Prepare submissions and reports for FDA and support other international agencies as required by product status. Interact directly with FDA and indirectly with international regulatory agencies on most projects/products at reviewer level. All significant issues will be reviewed with the manager
Provide business and product information to international regulatory staffs to enable development of strategies and requirements, and communicate that information to business teams
Provide feedback and on-going support to product development teams for regulatory issues and questions
Ensure personal understanding of all quality policy/system items that are personally applicable
Follow all work/quality procedures to ensure quality system compliance and high quality work
Bachelor’s degree in an engineering or scientific discipline
7+ years with Bachelor’s degree and work experience in medical device regulatory affairs
5+ years with engineering degree or advanced degree and medical device work experience
Engineering degree
Advanced degree in a scientific discipline (engineering, physical/biological or health sciences)
Experience in the preparation of 510(k) submissions for FDA and Technical Files for EU
Experience with international standards (ISO, GHTF, ICH)
Experience in medical device acquisition due diligence
Proficient computer skills (email, word-processing and spreadsheet software)
Effective cross-functional team player

Principal Regulatory Affairs Specialist Resume Examples & Samples

Prepare worldwide submissions for new products required to ensure timely approval for market release, product changes or clinical studies
Develop worldwide regulatory strategies/plans and lead implementation. Provide on-going expertise to teams for regulatory issues and questions
Provide comprehensive product information to worldwide peers for product introductions and training. Review advertising, promotion and training materials. Provide support to currently marketed products as necessary. This includes reviewing labeling, promotional material, product changes and determination of change on existing submissions and creation of submissions for changes requiring government or notified body approval
Negotiate directly with the FDA or notified body on all projects and/or products as needed. All significant issues will be reviewed by the manager
Regularly communicates with senior management and regulatory agencies. Influence and inspire alignment with business goals, internally and externally
Apply extensive technical or regulatory principles, theories and concepts and has full knowledge of other related disciplines
Develop strategies that leverage opportunities and experiences across functions
Develop technical solutions to complex problems that require the regular use of ingenuity and creativity. Play a leadership role in resolving conflicting and ambiguous inputs
Keeps current on global directives, harmonized standards and procedures and communicates changes to the business that may affect cross functional areas
Maintain Regulatory Affairs product files to support compliance with regulatory requirements
Participate in external and internal audits for compliance to regulations and harmonized standards, resolve audit findings, as needed
Provide training and support to other members of the department
Other tasks, as required
BA/BS/MS/Law degree
5 years or more of experience in regulatory affairs or FDA experience
Experience with internet/intranet technology and interactive software applications
Competency with Microsoft Office applications and Adobe Acrobat
Seasoned professional with significant experience with FDA requirements, guidance documents, 510(k) submissions, EU Medical Device Directive/Regulation, ISO 14971, ISO 13485, and other global regulatory requirements and quality standards
History of successful global device submissions
Through knowledge of GCP/GLP requirements
Recognized expertise in one or more areas of regulatory
Significant knowledge of other cross functions and business acumen. Expert problem solving skills and experience with complex issues that require resolution. Ability to work independently and make decisions that have significant impact to the company. Experience with interacting and building relationships with regulatory agencies
Knowledge of clinical study requirements
Excellent negotiation skills and written/oral communication skills
Demonstrated organizational , time management, and project management skills
Self-motivated. Acts on own initiative to identify opportunities and propose solutions outside the scope of their job responsibility

Associate Regulatory Affairs Specialist Resume Examples & Samples

Bachelor’s degree in scientific or engineering discipline
Proficient with MS Office software
Demonstrated technical writing skills

Senior Regulatory Affairs Specialist Resume Examples & Samples

Class II (or III) medical device (US) registration experience and US FDA experience required
European Union (EU) Class IIb/III medical device registration experience a plus
Regulatory experience in Asia a plus
Project management experience a plus
RAC-US certification desired
Experience in biologics a plus
Knowledge and use of relevant PC software applications and skills to use them effectively
Demonstrated ability to communicate effectively both verbally and in writing
In depth knowledge of U.S. and/or international medical device regulations and standards
Extensive knowledge of and ability to prepare regulatory documentation
Proven effective leadership and team skills. Strong interpersonal skills
Demonstrated ability to define problems and provide guidance to management in developing and implementing solutions
Analytical and creative thinking skills and the ability to solve complex problems
Or-

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