Senior Regulatory Affairs Resume Samples

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JM
J Mitchell
Jany
Mitchell
8292 Schultz Field
Boston
MA
+1 (555) 734 4399
8292 Schultz Field
Boston
MA
Phone
p +1 (555) 734 4399
Experience Experience
08/2016 present
Philadelphia, PA
Senior Regulatory Affairs Program Lead
Philadelphia, PA
Senior Regulatory Affairs Program Lead
08/2016 present
Philadelphia, PA
Senior Regulatory Affairs Program Lead
08/2016 present
  • Works with Management to ensure rapid and timely approval of new products and continued Regulatory support of marketed products
  • Assists in the development of best practices for Regulatory Affairs processes
  • Develops labeling specifications and approves proposed labeling, packaging, advertising and promotional materials after evaluating conformance to regulations
  • Partners with other functions to define and obtain data to assist with regulatory submissions
  • Provide Regulatory Affairs support during internal and external audits
  • Provides solutions to extreme complex problems
  • Creates detailed Regulatory Plans
07/2009 07/2016
Dallas, TX
Senior Regulatory Affairs Program Manager
Dallas, TX
Senior Regulatory Affairs Program Manager
07/2009 07/2016
Dallas, TX
Senior Regulatory Affairs Program Manager
07/2009 07/2016
  • Enhances and manages one or more medium-scale regulatory programs with generally-defined plans and delivery methodologies including continuous improvement activities and compliance related projects
  • Participates in establishing program objectives, timelines, milestones and budgets to achieve departmental and organizational objectives
  • Manage annual AOP forecasting for program
  • Recommends program decisions to management on processes related to new and changing regulations, guidance documents, enterprise policies, regulatory processes and product issues
  • Develop implementation plan, communicate and deploy program schedules to ensure timely completion
  • Influences across functions and businesses while balancing divergent objectives to gain cooperation of other functions on program objectives and execution plans on initiatives such as business development, major change projects, new product development, etc
  • Interface with a variety of management levels on significant matters, often requiring the coordination of activity across functional groups
10/2002 05/2009
New York, NY
Senior Regulatory Affairs Engineer
New York, NY
Senior Regulatory Affairs Engineer
10/2002 05/2009
New York, NY
Senior Regulatory Affairs Engineer
10/2002 05/2009
  • Supports and provides regulatory expertise to assigned medical device product development projects from initial kickoff to post marketing phase
  • Participate in regulatory process improvements work
  • Represent regulatory affairs in new product development as well as maintenance projects
  • Appreciate compliance work
  • Introduces regulatory methods/procedures that are new for the organization. Applies advanced regulatory process principles to multiple tasks
  • Supports pending domestic and international regulatory changes and executes quality plans to minimize impact
  • Provides the Regulatory assessment of Engineering Changes for medical device launch and sustaining activities
Education Education
Bachelor’s Degree in Science
Bachelor’s Degree in Science
Harvard University
Bachelor’s Degree in Science
Skills Skills
  • Excellent problem solving skills
  • Ability to mentor and lead problem solving
  • Ability to interpret authority regulations
  • Ability to work unsupervised under own initiative
  • Excellent communication skills
  • Supports pending domestic and international regulatory changes and executes quality plans to minimize impact
  • Supports Internal and External Quality Audits Supports Regulatory QMS procedure updates
  • Introduces regulatory methods/procedures that are new for the organization. Applies advanced regulatory process principles to multiple tasks
  • Provides the Regulatory assessment of Engineering Changes for medical device launch and sustaining activities
  • Formulates the solution for (technical) partial problems that cannot be found by combining previous experiences but by composing newly acquired regulatory knowledge
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15 Senior Regulatory Affairs resume templates

1

Senior Regulatory Affairs Therapeutic Resume Examples & Samples

  • 3+ years of related experience
  • Bachelor's Degree in a related field
  • Previous experience in the Pharmaceutical industry or in a Laboratory or Clinical Research position
  • Microsoft Office/Suite proficient
  • Excellent communication skills (written and verbal)
  • Strong attention to detail
  • Highly organized
  • Able to multitask efficiently and effectively
  • Degree in Life Sciences
  • Previous Regulatory Affairs experience
2

Senior Regulatory Affairs Therapeutic Resume Examples & Samples

  • Bachelor's Degree
  • 3-5 years' experience in either the Pharmaceutical industry or a laboratory
  • Intermediate proficiency in Microsoft Office Suite
  • Commitment to quality of all assigned projects
  • Excellent written and verbal communication skills
  • Commitment to regulatory affairs profession
  • Regulatory Affairs experience
3

Senior Regulatory Affairs Program Lead Resume Examples & Samples

  • Writes, coordinates, compiles, and submits Regulatory documents to FDA, EU notified bodies, and other Regulatory Agencies, including EPA and International Authorities
  • Also includes the preparation of international documents, including Technical Files and Design Dossiers
  • Works with Management to ensure rapid and timely approval of new products and continued Regulatory support of marketed products
  • Creates detailed Regulatory Plans
  • Includes in-depth team involvement, including Core Team membership for complex projects
  • Evaluates proposed product modifications for Regulatory impact on a world-wide basis
  • Completes Regulatory Assessments as needed
  • Ensures compliance with regulatory agency regulations and interpretations
  • Ensures preparation of necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides
  • Prepares responses to regulatory agencies’ questions and other correspondence
  • Gathers and assembles information necessary for submissions in accordance with regulations and relevant guidelines
  • Develops timelines for submissions under the direction of senior regulatory affairs staff
  • Provides solutions to extreme complex problems
  • Provides regulatory advice to project teams
  • A minimum of 6 years of related professional experience in an FDA regulated industry is required
  • A minimum of 2 years of regulatory affairs experience in the pharmaceutical or medical device industry is required, inclusive of writing, coordinating, compiling, and submitting regulatory documents to the FDA
  • Direct experience with PMA and EU Class III devices is desirable
  • Knowledge of international regulations is preferred
  • Excellent communication skills, both verbal and written is required
  • Must have good organizational skills, analytical thinking, problem solving and investigative skills
  • Proficiency in Microsoft Office and related applications is required
  • This position is located in Irvine, CA and will require up to 10% domestic travel
4

Senior Regulatory Affairs Program Lead Resume Examples & Samples

  • Represent regulatory affairs on product development teams by attending team meetings and providing the global regulatory plan, regulatory assessments and regulatory decisions
  • Prepare regulatory documentation for Synthes devices, including Design Dossier, Technical file as well as IDE, 510(k) and PMA documentation for submission to the Food and Drug Administration (FDA). This includes the resolution of regulatory issues and questions from regulatory agencies and Notified Bodies during the pre-market product development phase
  • Assist in the preparation of approval documents to support rest of world registrations. Additional activities may require notarization and legalization of documents, and requesting of Certificates to Foreign Government and Free Sale Certificates
  • Review engineering changes to currently marketed products and prepare internal regulatory assessments for documenting decisions to submit or not to submit in accordance with relevant regulations and guidance
  • Review product labeling and product support information for currently marketed products to ensure that product information and claims are consistent with relevant regulations and guidance
  • Assist with the maintenance of the regulatory database with accurate and current regulatory information
  • Maintain current knowledge to ensure compliance to the applicable regulatory and corporate standards/ requirements (FDA Quality System Regulations, European Quality Standards, ISO 9001/13485, MDD, CMDCAS/CMDR, etc.)
  • Attend conferences, seminars, professional meetings, and other public forums that are relevant to the regulatory interests of Synthes
  • Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times
  • Diligently participate in our compliance program-related activities as denoted by your supervisor or our Chief Compliance Officer
  • BA/BS Degree preferred or equivalent
  • Six to eight years of relevant regulatory experience in medical devices
  • Knowledge of MDD/MDR and relevant guidance
  • Knowledge of U.S. FDA medical device regulations and guidance
  • Knowledge of orthopedic implants a plus
  • Excellent written and oral communication skills in English and German or English and French
  • Ability to handle multiple tasks and be detail oriented
5

Senior Regulatory Affairs & Pharmacovigilance Executive Resume Examples & Samples

  • Manage the compilation and preparation of regulatory documents, information, data technical files to support approvals for new product registration, renewals and changes (NDA and LCM licenses)
  • Review the content of submission package provided by HeadQuarters (HQ) according to local Health Authority (HA) requirements
  • Identify any necessary documentation for the submission to local HA and prepare the application form, as required, according to HA requirements
  • Perform submission to HAs
  • Support approval and post-approval activities and ensure Registration Information Management System (RIMS) update with approval information within agreed timeline
  • Handle HAs or agents’ requests and demands on quality, clinical and non-clinical information according to NNAS standards/SOPs
  • Ensure timely submission and follow-up of labelling variations to the local HAs, in cooperation with the key stakeholders
  • Maintain licence to operate in affiliate by timely management the renewals and LCM activities
  • Support to fulfil any post-approval commitments required by HAs
  • Update and maintain paper/electronic document archival systems
  • Coordinate actions effectively and proactively with other functions to support product launches, LCM activities and supply in due time
  • Perform key tasks identified as business critical for Regulatory, Quality and/or Pharmacovigilance functions in Malaysia and Singapore when required, in the absence of the responsible person. Key back-up areas are identified and reviewed periodically
  • Minimum 3 years experience in pharmaceutical industry, with minimum one year experience in RA associate or similar regulatory position
  • Advanced knowledge of pertinent local regulations required
  • Experience with regulatory intelligence activities and pharmaceutical registration databases is preferred
  • Knowledge of diabetes and diabetes management beneficial
  • Knowledge of other therapeutic areas and/or biotech products relevant to Novo Nordisk beneficial
  • Previous supervisory/management experience required depending on team size
6

Senior Regulatory Affairs Resume Examples & Samples

  • Prepare, review and file appropriate FDA premarket submission to ensure devices are commercially available in the U.S.: 510(k)s, pre-IDEs, IDEs, etc
  • Create regulatory dossiers, i.e. technical files or Design Dossier for CE Marking; generate STED to support business access to international markets
  • Maintain current knowledge of ISO 13485, FDA and Medical Device Directive, applicable regulations, guidance and standards applicable to company products
  • Responsible for monitoring the progress of clinical trials, regularly checking for compliance and progress via phone, e-mail and on-site visits where necessary
  • Maintain document control; including regulatory documents, quality agreements, QS policies and procedures, etc
  • Monitor corrective and preventive actions
  • Analyze data, assist with input and review documentation related to complaints, CAPAs, protocols, regulatory submissions, etc
  • Investigate customer complaints and non-conformance issues as directed by QA management
  • Develop quality policy and establish quality objectives
  • Provide resources necessary to maintain QMS
  • Conducts Periodic management Reviews and ensures that quality policy and procedures are enforced at all organizational levels
  • Maintain regulatory documentation as it relates to Customer Complaint Handling and Corrections & Removals
  • Knowledge and experience in gaining FDA clearance for Class II medical devices
  • A minimum of 4-5 years of regulatory affairs/Quality Assurance working experience, mainly for medical devices. Must have knowledge of U.S. and/or European/International regulations and standards
  • Experience in preparing regulatory submissions; Experience interacting with FDA and/or other regulatory agencies
  • Ability to develop strategic regulatory plans and to communicate these effectively within the relevant structures
  • Strong project management skills essential – able to work across functions and departments and sometimes across companies to co-ordinate and deliver to an agreed RA submission plan
  • ~10%
7

Senior Regulatory Affairs Data Management Specialist Resume Examples & Samples

  • Usually works with minimum supervision having some latitude for independent action or decision, conferring with more senior and supervisory staff when indicated, and keeps supervisor regularly informed on status of work
  • Developing and applying basic knowledge and understanding of regulatory data, the information systems in which they are stored, processes and procedures
  • Project management, writing, coordination, and execution of regulatory data management items
  • Assisting in SOP development and review
  • Assisting in the creation and maintenance of regulatory data based upon product and information system changes
  • Providing regulatory data management input to new product development and product lifecycle planning
  • Evaluating regulatory data management impact of proposed changes to launched products
  • Determining and communicating regulatory data management requirements
  • Represent the Regulatory Affairs team on projects impacting regulatory affairs data management
  • Support review and approval of product labeling for accuracy of regulatory data attributes before release
  • Providing regulatory data management input for and appropriate follow-up to inspections and audits
  • Assisting in the development and implementation of SOPs and systems to track and manage product-associated regulatory data
  • Reviewing change management to determine the level of change and potential regulatory data management requirements
  • Identifying product-associated regulatory data problems and developing proposals for solutions
  • Advising responsible personnel on regulatory data management requirements
  • Monitoring impact of changing regulations on regulatory data management requirements
  • Identifying issues early in the product attribute data preparation process that could impact product launch
  • Compiling, preparing, reviewing and submitting regulatory data to authorities
  • Support the creation and maintenance of regulatory data in Enterprise Resource Planning (ERP), Product Lifecycle Management (PLM) systems and others as required
  • Support the creation, maintenance and submission of regulatory data to comply with global Unique Device Identifier requirements
  • Generate, compile and communicate divisional performance and product trending metrics
  • Knowledge of the Quality System Regulations (21 CFR) and Medical Device Directives (MDD) in regarding to regulatory data management
  • Knowledge of ERP and PLM database systems
  • Mastery of Microsoft Excel
  • 1-3 years IS experience
  • Effective interpersonal communication skills
  • Advanced PC skills
  • Previous experience in Information Systems (IS), database administration, or help desk environment
8

Senior Regulatory Affairs Office Resume Examples & Samples

  • Manage staff in accordance with organization’s policies and applicable regulations. Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems. Approve actions on human resources matters, including salary administration
  • Responsible for performance (quality, profitability, utilisation) of direct reports, ensuring consistent regulatory support, in accordance with Global Regulatory Affairs business plans. Ensures objectives of individual staff and teams are in line with overall Regulatory Affairs objectives by facilitating regular communications
  • Participate in the selection and on-boarding process for new Regulatory staff by conducting candidate review and participating in the interview process. Ensure staff have the appropriate materials, systems access and training to complete job responsibilities
  • May prepare a single service regulatory or technical proposal for senior review and/or propose budgets for less routine projects, out of scope activities and potential budget efficiencies. Deliver business development presentations to customers with confidence and detailed knowledge, as directed
  • Ensures compliance with regulatory processes, ensuring readiness for internal or external project audits
  • May represent region or site on a regulatory, technical or cross-functional Initiative
  • Demonstrate success in leading teams or previous experience in a supervisory capacity
  • Advanced negotiating and influencing skills and the ability to identify and resolve issues, using flexible adaptable approach. Remains calm, assertive and diplomatic in challenging interactions with customers
  • Understands and promotes Corporate and Global Regulatory Affairs Business Unit strategies, communicating this in a positive manner to staff
  • Ability to provide fair, timely, appropriate and constructive feedback and guidance to staff
  • Ability to earn trust of staff, acting in confidence and with sensitivity when dealing with personnel issues, staff expectations and conflict management
  • Strong software and computer skills, including MS Office applications
9

Future Senior Regulatory Affairs Engineer Opportunities Resume Examples & Samples

  • Support product engineering and manufacturing teams on regulatory issues, including review of design input, risk management and test documentation
  • Assess the impact of the product/process changes and determine regulatory pathway for US, EU and Canadian markets
  • Prepare and submit regulatory filings for the above markets including 510(k)s, Non-filling justifications, Technical File updates, Canadian License Applications
  • Work with other international regulatory counterparts to coordinate global regulatory submissions/approvals
  • Provide oversight of third party agency testing (UL, EMC, biocompatibility, sterilization assurance) as required
  • B.S. or higher in Biomedical Engineering, Electrical Engineering or Mechanical Engineering preferred
  • Non-technical degree with equivalent complex medical device experience acceptable
  • 8 years relevant experience working in a medical device company
  • 6 years of experience in regulatory submissions and technical documentation for a medical device company
  • Experience working with cross-functions teams including engineering, manufacturing, regulatory, quality etc
  • In-depth understanding of FDA, CE mark and Health Canada regulations
  • Ability to work with cross function project teams and understand complex products
  • Ability to work in a fast paced environment and handle multiple projects simultaneously
  • Strong verbal and written communication skills, proven ability to translate technical documentation into effective regulatory submissions
  • Ability to review and provide critical feedback on design documentation
  • Able to learn internal procedures and processes and implement the same on project teams
  • Good interpersonal skills and project management skills
10

Senior Regulatory Affairs Program Lead Resume Examples & Samples

  • Leads the submission of licenses and authorizations for the maintenance of existing products, international registrations, and dossiers
  • Guides conformance with applicable regulations in product development, support of claims, content labeling, and promotional materials
  • Defines data and information needed for regulatory approvals
  • Develops labeling specifications and approves proposed labeling, packaging, advertising and promotional materials after evaluating conformance to regulations
  • Provide Regulatory Affairs support during internal and external audits
  • Plans schedules for regulatory deliverables on a project and monitors project through completion
  • Assists in the development of best practices for Regulatory Affairs processes
  • Represents Regulatory Affairs on cross-functional project teams
  • Partners with other functions to define and obtain data to assist with regulatory submissions
  • Excellent written, verbal communication and presentation skills
  • Leverages a deep scientific and technical understanding of regulated products under scope of responsibility to provide strategic guidance and support for product development and life-cycle management of products
  • Integrates and executes results-oriented Regulatory Affairs strategies that are aligned with organizational objectives. Takes accountability for the achievement of business goals and objectives
  • Tactical and strategic regulatory knowledge necessary to gain approval and ensure maintenance of legal marketing status of all products, including Class III devices (especially EU)
  • Ability to partner and influence key stakeholders on NPD and Lifecycle teams
  • Clearly defines and prioritizes decision criteria and considers benefits, risks, and Credo of each alternative before making decisions. Considers all of the available facts when situations are ambiguous in order to make the best possible decision (for example, when regulations are unclear)
  • Consistently manages large amounts of changing, complex, and/or ambiguous information from multiple sources and makes timely and effective decisions for the execution of project objectives
  • Knowledgeable in US, EU and International Regulations
  • A minimum of a Bachelor’s degree from accredited college or university is required. A degree focused in science, biomedical engineering, medical/ scientific writing, public health administration preferred
  • 6 years working in regulated healthcare industry is required. Medical device experience preferred
  • Experience in the preparation, and submission of US Regulatory files (510(k)s, PMAs) and/or European technical files and design dossiers is required
  • Knowledge of US, EU and International Regulations required. Knowledge of International Regulations in China, Japan, Brazil and Russia preferred
  • Experience with Medical Device Navigation Software and Instruments and/or Medical Device Software is preferred
  • This position is located in Raynham, MA and may require approximately 10% travel.Regulatory Affairs
11

Senior Regulatory Affairs & Export Control Specialist Resume Examples & Samples

  • You coordinate every necessary activities for preparation and evaluation of registrations dossiers and legal documents associated, and to direct and coordinate regulatory activities related to preparation of files for the new products registration processes, modifications, renewals and technical evaluations requirements for registration of products in the countries where they are needed; asking Global Regulatory support, preparing and sending required documents and giving support to local organizations for registration processes, negotiating with authorities any problem related with registrations in process, to obtain the approval for initiate or continue the products commercialization
  • You participate together or in consultation with the Regulatory Affairs Manager in local legislation and standardization, and to negotiate with in charge authorities the regulatory affairs that guarantee the establishment of an adequate regulatory environment for products to facilitate business growth and clearer communication in processes with authorities, in countries of regions where it applies
  • You represent the company with local authorities and associations in affairs related to current legislation (product launching, regulatory activities, quality affairs, etc.)
  • You monitor the legal and regulatory developments, changes or implementations in the countries of the region
  • You establish and maintain contact with regulatory authorities
  • You direct, compile, evaluate and notify involved departments about reports of adverse incidents received through Global Regulatory. To evaluate and notify about adverse incidents that should be notified to the authority according to current legislation
  • You actively support local organizations and marketing, sales and logistic departments to obtain documents related with regulatory affairs such as certificates, declarations, etc., needed ad required for tender processes, contracts and /or any commercial activity
  • You define, implement and monitor a follow up system for all registers of the region
  • You generate the reports required by the company regarding the areas under his/her responsibility
  • You perform other functions according to the requirements of the immediate Superior
  • You collaborate closely with the Legal, sales and Regulatory Affairs Manager in any projects or activities that the department requires
  • You will be backup for the Regulatory Affairs Manager in all Regulatory Affairs and Export Control matters
12

Senior Regulatory Affairs & Quality Manager Resume Examples & Samples

  • Plan and carry out drug registration activities
  • Ensure complete records/files of all product dossiers and updates submitted and approved by the regulatory authorities are maintained and archived including on-line submissions
  • Manage the Import License and associated Product List with timely updates for additions/changes
  • Review of promotional materials for regulatory compliance
  • Provide business-related support on regulatory activities, regulatory intelligence, complaints on competitors, Special Permit applications, etc
  • Handle pack management activities, including compliance to Local Labelling Requirements and processing pack changes when required
  • To manage product information updates with respect to Roche and local regulatory requirements and for Roche databases
  • To liaise closely with Regulatory Authorities and Professional Bodies and foster good rapport with them
  • To be responsible as Company Pharmacist
13

Senior Regulatory Affairs Product Specialist Resume Examples & Samples

  • Serve as the Regulatory representative on cross-functional teams supporting products throughout the stages of development and commercialization
  • Perform regulatory assessment on all proposed change control; gather required data as needed to defend a Regulatory filing strategy; coordinate and prepare post-approval supplements if warranted
  • Manage, prepare, publish using eCTD software well-organized, scientifically sound CMC and safety-related regulatory submissions which include ANDAs, Amendments, Annual reports, PSUR and Supplements that comply with applicable regulatory requirements in eCTD format
  • Coordinate and communicate timelines and deliverables with Regulatory Operations, Labeling and other key departments to facilitate quality CMC and safety-related regulatory submissions, including ANDAs, Amendments, Annual reports, PSUR and post approval Supplements
  • Review technical reports, summary documents and change controls (chemistry, manufacturing and analytical controls) for appropriate content and justifications as well as for adherence to regulatory guidelines, strategies, and commitments
  • Work with partners to create product labeling compliant with FDA, and compendial requirements for drug products
  • Contact FDA and other Regulatory authorities for review status updates for pending applications and supplements
  • Hands on experience in leading a variety of Regulatory submission activities (ANDAs, Post Approval Supplements, PSURs, Annual Reports.)
  • Familiar with a variety of pharmaceutical concepts, practices and procedures and the functioning of a regulatory affairs department
  • Ability to interpret Regulatory Authority policies and CMC guidance and correctly apply them as appropriate throughout the product life-cycle
  • Ability to critically review detailed scientific information and assess whether technical arguments are presented clearly and conclusions are adequately supported by data
  • Ability to assess project risks, and where appropriate, recommend contingency plans and strategies to mitigate regulatory risks
  • Familiarity with Trackwise
  • Ability to manage a variety of assignments
  • Detail oriented and highly organized
  • Strong interpersonal skills and ability to deal effectively with a variety of personnel including senior management
14

Senior Regulatory Affairs Executive Resume Examples & Samples

  • Excellent planning, time management and organisational skills
  • First class communication skills, both written and verbal
  • Knowledge of EU, UK and Ireland regulatory requirements
  • Strong influencing and negotiation skills with evidence of effective cross functional working
  • Driven and capable of delivering results efficiently and effectively
  • LI-PD2-EUR
15

Senior Regulatory Affairs Program Lead Resume Examples & Samples

  • Bachelor degree from accredited college or university in science, biomedical engineering, medical/scientific writing, public health administration is required
  • A minimum of 6 years regulatory affairs or related/equivalent experience is required
  • RAC (Regulatory Affairs Certification) by Regulatory Affairs Professional Society is strongly preferred
  • Leads the submission of licenses and authorizations for the maintenance of existing products, international registrations, and dossiers is required
  • Develops labeling specifications and approves proposed labeling and packaging, after evaluating conformance to regulations is required
  • Partners with other functions to define and obtain data to assist with regulatory submissions is required
  • Plans schedules for regulatory deliverables on a project and monitors project through completion is required
  • Gathers and assembles information necessary for submissions in accordance with regulations and relevant guidelines is preferred
  • Provides solutions to extreme complex problems in which data analysis requires an evaluation of intangible variables is preferred1099170515
16

Senior Regulatory Affairs Training Manager Resume Examples & Samples

  • Identifying, developing, training and tracking of training to all Regulatory Affairs employees
  • Overseeing the lifecycle of training programs from the identification of training needs, content development, updates including version control and change log maintenance
  • Collaborate with departmental subject matter experts in the design of new training materials and updates to existing content
  • Initiate 'Train the Trainer' programme and development materials
  • Represents Regulatory Affairs in internal/external audits
  • Promote training and development capabilities within the department and PPD as appropriate, and provide individual and group training consultation
  • Bachelor's degree or equivalent and relevant formal academic/ vocational qualification
  • Minimum 8 years in Regulatory Affairs
  • Minimum of 5 years of training or education experience
  • In some cases, a combination of performance, education and prior directly related experience may be considered as equivalent
  • Demonstrates strong knowledge of regulatory affairs and understands its role in the drug development/approval/life cycle process eg: clinical trials support,
17

Senior Regulatory Affairs Training Manager Resume Examples & Samples

  • Minimum 8 years in Regulatory Affairs. In some cases, a combination of performance, education and prior directly related experience may be considered as equivalent to the above requirements provided that the individual possesses the following knowledge, skills, and abilities to perform the job requirements satisfactorily
  • Demonstrates strong knowledge of regulatory affairs and understands its role in the drug development/approval/life cycle process eg: clinical trials support, preparation of marketing authorisations, life cycle management, regulatory intelligence and CMC
  • Able to define, develop and deliver a variety of RA training and development programs
  • Has thorough understanding of ICH/GCP guidelines and PPD procedural documents and regulatory requirements
  • Ability to lead and oversee the planning and logistics of functional training initiatives as needed in an efficient and cost- efficient approach
  • Demonstrates confident and engaging presentation skills
  • Advanced skills in using MS Word, Excel, PowerPoint
18

Senior Regulatory Affairs Engineer Resume Examples & Samples

  • Supports and provides regulatory expertise to assigned medical device product development projects from initial kickoff to post marketing phase
  • Creation and execution of Regulatory Strategies and Plans for assigned medical device products in the domestic and international markets, including assessments of the regulatory impact of changes to design, materials, labeling, software, and suppliers
  • Develops the standards strategy for medical devices and supports activities required to maintain regulatory compliance as new or revised versions of standards are released
  • Prepares and submits US FDA pre-sub, 510(k), and other product submissions according to FDA guidelines
  • Creates EU Technical File and Declaration of Conformity documents (MDD, RED, LVD, RoHS, etc.) and Canadian licensing submissions according to international guidelines
  • Maintains expertise in domestic and international regulations and standards, with a focus on assigned medical devices and regional focus on the US (FDA), EU (MDD), and CA (Health Canada)
  • Support the international regulatory specialist team with inputs, as needed, into the registration packages they prepare
  • Supports pending domestic and international regulatory changes and executes quality plans to minimize impact
  • Provides the Regulatory assessment of Engineering Changes for medical device launch and sustaining activities
  • Reviews and approves medical device labeling plans, instructions for use, labels, and marketing communications
  • Supports Internal and External Quality Audits Supports Regulatory QMS procedure updates
19

Senior Regulatory Affairs Engineer Resume Examples & Samples

  • Formulates the solution for (technical) partial problems that cannot be found by combining previous experiences but by composing newly acquired regulatory knowledge
  • May lead multi-disciplinary regulatory change projects, managing a number of people. Works independently and provides consultative advice within specific functional regulatory areas
  • Introduces regulatory methods/procedures that are new for the organization. Applies advanced regulatory process principles to multiple tasks
  • Proficient in regulatory area of specialization and contributes in other disciplines. Determines feasibility of regulatory concepts or projects. Has basic knowledge of related disciplines
  • Bachelor’s degree with 5+ years of related experience in regulatory affairs engineering; or a Master’s degree with 3+ years of related experience in regulatory affairs engineering
20

Senior Regulatory Affairs Program Manager Resume Examples & Samples

  • Enhances and manages one or more medium-scale regulatory programs with generally-defined plans and delivery methodologies including continuous improvement activities and compliance related projects
  • Participates in establishing program objectives, timelines, milestones and budgets to achieve departmental and organizational objectives
  • Recommends policies and procedures that affect regulatory programs
  • Recommends program decisions to management on processes related to new and changing regulations, guidance documents, enterprise policies, regulatory processes and product issues
  • Leads projects and develops sound regulatory strategies for long term registrations of new and modified medical devices
  • Influences across functions and businesses while balancing divergent objectives to gain cooperation of other functions on program objectives and execution plans on initiatives such as business development, major change projects, new product development, etc
  • Evaluates regulatory risks and opportunities with acquisitions/divestitures and assists with due diligence and post-acquisition assessments
  • Leads in the understanding and awareness of US, EU and other international regulatory requirements to ensure compliance. Disseminates and provides guidance and continuing education as applicable
  • Establishes daily tasks, metrics development and implementation where necessary for successful program execution
  • Interface with a variety of management levels on significant matters, often requiring the coordination of activity across functional groups
  • Prepares and provides guidance regarding required documentation (510(k)s, technical documentation files, dossiers) for domestic and foreign submissions and registrations
  • Reviews and approves engineering changes, device labeling and marketing materials for compliance with FDA submissions and applicable regulations
  • Supports IIA activity; working closely with Quality and ENT Medical Officer
  • Assists with audits and inspections, if required
  • Represents the company in key professional meetings, seminars and other relevant activities
  • Travel requirement: Less than 10%
  • Bachelor's degree required in a technical discipline
  • 7+ years of related experience including broad multi-functional business experience along with 5+ years of project management experience, or
  • Masters degree and 5+ years of related experience including broad multi-functional business experience along with 3+ years of project management experience
  • Expert in the field of Regulations and Standards affecting the Medical Device Industry
  • Graduate degree in science, engineering, or law preferred
  • Demonstrated competencies in project management
  • Experience with 510(k) applications, IDEs, PMA or PMA supplements and US device regulations and/or experience with other international medical device regulations and submissions
  • Extensive experience with EU Medical Device Directive (MDD) 93/42/EEC and exposure to EU Medical Device Regulation (MDR) 2017/245
  • Experience in due-diligence evaluations of companies and/or product acquisitions
  • Knowledge of principles and requirements of promotion, advertising and labeling
  • Proven success with working and negotiating with people from various disciplines, organizations, and cultures
  • Ability to follow scientific arguments, identify regulatory scientific data needs, solve regulatory issues, and define regulatory strategy
  • Ability to work in a highly matrixed and geographically diverse business environment
  • Ability to work within a team and as an individual contributor and ability to mentor junior team members in a fast-paced, changing environment
  • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
  • Ability to work independently with no oversight
  • Ability to identify and solve problems in a strategic manner and to manage complex projects
  • Ability to be proactive and not reactive, to anticipate changing business and regulatory environments
  • The employee must frequently lift and/or move up to 10 pounds
21

Senior Regulatory Affairs Program Manager Resume Examples & Samples

  • Develop thorough understanding of EU MDR requirements as well as subsequent guidance documents and implementing acts and provide guidance to organization on interpretation and impact to business
  • Communicate effectively with Regulatory and cross-functional leadership to ensure clear expectations, demonstrate progress and identify issues
  • Lead recurring meetings with cross-functional team of SMEs
  • Partner with EU MDR leaders from other business unts/groups regarding common Medtronic interpretation and guidance, deliverables, pace and progress across the organization to ensure a harmonized approach for achieving compliance
  • Develop implementation plan, communicate and deploy program schedules to ensure timely completion
  • Define objectives and milestones for successful program execution
  • Define and report metrics (scorecards) on program progress, implementation and effectiveness; deliver management reporting and escalation when required
  • Lead program execution to enable results and maintain commitments, including escalation to management for resolution of non-standard solutions
  • Manage annual AOP forecasting for program
  • 8+ years (with Bachelor’s) or 6+ years (with Master’s) of experience in Regulatory Affairs or other function familiar with technical files and medical device product development process
  • Knowledge of current European medical device directives (MDD/AIMDD) and CE mark process
  • Experience driving change management initiatives across an organization
  • Experience delivering presentations at senior management levels in an organization
  • Ability to work independently or collaboratively to determine and develop approaches to solutions with very little to no supervision or direction
  • Experience influencing stakeholders at multiple levels in an organization
  • Experience with MS Project, MS Excel, MS PowerPoint, MS Word
22

Senior Regulatory Affairs Engineer Resume Examples & Samples

  • Provide guidance on product regulation and translate into meaningful business requirements
  • Gain market access for our regulated products including submissions
  • Communicate with regional and business teams and prepare responses on all governing agency actions
  • Review promotional labeling
  • Represent regulatory affairs in new product development as well as maintenance projects
  • Participate in product release process
  • Participate in regulatory process improvements work
  • Ability to work unsupervised under own initiative
  • Ability to interpret authority regulations
  • Ability to mentor and lead problem solving
  • Appreciate compliance work
  • Appreciate the role as specialist