Senior Regulatory Affairs Job Description
Senior regulatory affairs
provides technical expertise to ensure conformance to ISO, FDA (Food & Drug Administration) & MDD (Medical Devices Directive) based quality systems.
Senior Regulatory Affairs Duties & Responsibilities
To write an effective senior regulatory affairs job description, begin by listing detailed duties, responsibilities and expectations. We have included senior regulatory affairs job description templates that you can modify and use.
Sample responsibilities for this position include:
Monitor and assess the impact of existing, modified and new standards pertaining to CLS products for the US and EU markets
Monitors FDA, EU and other agency laws and regulations, and provides their interpretation to regulatory leadership
Lead interactions w/ FDA & international agency personnel to expedite approval of pending applications & resolve regulatory matters
Preparing, reviewing and approving data elements for use in regulatory dossiers in accordance with EU and international requirements for medicinal products/clinical trial clearances
Assist in the Compliance to the Medical Device Directive (MDD) in the EU, Canadian Medical Device Directive, and other regulatory agencies
Assess and report back the US and EU impacts of product changes
Review and approve labels and promotional materials for compliance to FDA and other trade requirements
Coordinates and prepares regulatory submissions, including EU/IVDD Technical Documentation, classification requests, pre-submissions, 510(k) premarket notifications, Premarket Approval Applications (PMA), and critical registrations worldwide identified for the commercialization phase of GPDS
Prepare US and International regulatory submissions, including, but not limited to 510(k)’s, IDE/IDE Supplements, PMA/PMA Supplements, Annual Reports, HDEs, IND/NDA Supplements, Design Dossiers/Change Notifications, and Technical Files
Participate and provide guidance and support to product development teams on both US and international issues
Senior Regulatory Affairs Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Senior Regulatory Affairs
List any licenses or certifications required by the position: RAC, MDD, MDR, US, CE, RAPS, EU, GMP, CMC, CC
Education for Senior Regulatory Affairs
Typically a job would require a certain level of education.
Employers hiring for the senior regulatory affairs job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Science, Engineering, Technical, Chemistry, Biology, Medical, Pharmacy, Life Sciences, Education, Life Science
Skills for Senior Regulatory Affairs
Desired skills for senior regulatory affairs include:
FDA
Medical device regulations
English language
Standards
EU
FDA law
Medical Devices Directive
ISO 13485
International
MDD
Desired experience for senior regulatory affairs includes:
Provide regulatory input to CTD and eCTD requirements to prepare the company's readiness to meet regulatory compliance requirements
Support the development of regulatory strategy documents, guidance and best practices documents related to regulatory activities
Prepare SOPs as required to support regulatory compliance of US submission activities and drug development functions along with change control system
Provide early feedback and guidance regarding product concepts and Design Control decisions
Represent the Regulatory Affairs function on the assigned new product development teams
Represent the Regulatory Affairs function in Product Life Cycle management, which would include sustaining engineering (SE) project teams and initiatives
Senior Regulatory Affairs Examples
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Senior Regulatory Affairs Job Description
Job Description Example
Our innovative and growing company is looking for a senior regulatory affairs. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for senior regulatory affairs
- Plan, organize and compile various regulatory documents for submission to the US FDA and other regulatory bodies
- Communicate with FDA and other regulatory bodies on routine matters
- Responsible for development and implementation of product regulatory strategies and plans for submissions to FDA, and other regulatory authorities, as appropriate
- Ensure compliance with all U.S. and international regulatory requirements pertaining to pre-and post-marketing activities, including external regulatory agency inspections
- Review submissions for completeness, accuracy, verification of analytical and clinical data, and compliance with submission standards and expectations
- Work on new product development teams, current product and product improvement projects providing regulatory and compliance guidance on current standards & requirements
- Responsible for Company’s compliance with regulatory agencies and all applicable standards worldwide
- Provide counsel, training, and interpretation of FDA and other regulatory issues to Company personnel and assist as a liaison between the Company and regulatory authorities
- Lead or participate in Efficiency Projects and other Special Assignments
- Support tender responses requiring product registration related information
Qualifications for senior regulatory affairs
- Proficient in using Microsoft Word, Access, Excel and Lotus Notes
- Prior experience and/or a desire for people mentoring and leadership a plus
- Creates and executes complex regulatory strategies and plans for the new GenCell products including both research and clinical portfolio with minimum supervision
- Provides a high level of regulatory expertise and experiences to the Core Teams, while serving as a project member or Extended Team member
- Suggests opportunities for improvement that have a significant impact (cost, cycle time, quality, ) and assists in developing or executing implementation plan
- Holds understanding of technical/scientific principles that relate to BDB regulated products, specific product lines, or manufacturing processes
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Senior Regulatory Affairs Job Description
Job Description Example
Our growing company is looking to fill the role of senior regulatory affairs. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for senior regulatory affairs
- Collaborate with our business unit leaders across Canada to understand strategic imperatives and progress on results how best to support them
- Work with Senior Legal Counsel other team members to implement processes that minimize risks and develop strategies that maintain flexibility with regards to new or existing services our companies offer or intend to offer
- Work with management to devise strategies to ensure rapid and timely approval of devices and continued regulatory support of marketed devices and other products
- Review and approve labeling, manufacturing, marketing and clinical protocol procedures and documents
- Review and provide regulatory authorization for Change Orders (COs)
- Review and analyze technical data generated by Research and Development, Marketing/Sales, Clinical Research, Quality Assurance or other related departments
- Respond to requests from foreign governments and/or distributors to prepare and submit documentation for marketing approvals in other countries, provide routine regulatory information to associates and affiliates
- Work closely with product development teams as a core team member representing Regulatory Affairs
- Work closely with QRA management and regulatory colleagues in developing regulatory strategies
- Establish and maintain official CDx regulatory submission files
Qualifications for senior regulatory affairs
- 7 years Regulatory Affairs registration experience in medical device and/or in vitro diagnostic device companies
- Working knowledge of new product development in medical devices, in vitro diagnostic devices and/or pharmaceuticals
- Exercises independent judgment and discretion within a defined range of policies and practices
- Multiplexes well to handle multiple tasks and to prioritize and schedule work to meet business needs
- As the position will involve advocacy and policy making, proven strong writing skills are essential
- BA communications, political science, law or other degree demonstrating strong written and advocacy skills
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Senior Regulatory Affairs Job Description
Job Description Example
Our growing company is hiring for a senior regulatory affairs. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for senior regulatory affairs
- Review and load new product listing, product delisting, registration of new manufacturing sites, into the US FDA registration and listing databases
- Complete inquiries and requests from internal and external sources in regards to US FDA import/export processes and practices and US custom holds
- Complete a Letter to file following all US FDA regulations and guidance’s
- Support as requested by supervisor with all other request for information and documentation associated with US regulatory laws and FDA requirements
- Establish and maintain strong relationships with internal and external stakeholders
- Stay abreast of changes in the regulatory environment of companion diagnostics and communicate changes to LBS QRA for adoption in regulatory strategies accordingly
- Develop organizational capability and provide functional leadership for Regulatory Affairs and Design Assurance Quality Engineers
- Utilize strong breadth and depth of experience in regulatory submissions and approvals, inclusive of 510(k), PMA, pre-submission briefing packages and meetings, CE-IVD, Canada device license applications
- Part of management team, develops regulatory strategies aimed at achieving marketing authorization and competitive, appropriate product labeling and fostering business growth in target markets
- Ensure budget, schedules, and department performance requirements are met
Qualifications for senior regulatory affairs
- BS, B.Sc., BA university degree in a technical or scientific discipline or cumulative related work experience
- Regulatory Affairs Certification a plus
- Knowledge of the Telecommunications and Broadcasting industry
- 8 years experience in a compliance or advocacy role
- A minimum of a Bachelor’s degree from accredited college or university is required
- 4+ years working in regulated healthcare industry is required
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Senior Regulatory Affairs Job Description
Job Description Example
Our company is looking to fill the role of senior regulatory affairs. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for senior regulatory affairs
- Ensure full compliance with local and EU requirements towards RA activities
- Successfully execute domestic and international regulatory affairs and compliance activities for company product lines with particular emphasis on the endoscopy division and compilation of US regulatory submissions for Korean developed product offering
- Prepare global submissions for new products and their product changes as required to ensure timely approval for clinical studies and market release
- Review significant regulatory issues with supervisor, as necessary, and negotiate submission issues with regulatory bodies
- Participation on New Product Development cross-functional core teams to provide regulatory guidance and strategies/plans for registrations, submissions and worldwide compliance requirements
- Compiling, reviewing and approving, as required, regulatory despatches in accordance with national requirements to ensure appropriateness and consistency in consistency in content and presentation of information both within and between registration applications
- Deputising for the Regulatory Affairs (RA) Manager, where appropriate and when required
- Completing the requirements of the Registration Programme as agreed with the Advanced Wound Management (AWM), Global Business Unit (GBU) and Operations departments
- Providing on-going regulatory advice to project teams throughout product and process development to ensure regulatory concerns are planned and accounted for and the relevant data generated to meet project objectives
- Interpreting individual country legislation relevant to the Smith and Nephew AWM business
Qualifications for senior regulatory affairs
- Knowledge of US and European regulatory processes is required
- Bachelor’s degree in science, medical or technical field and a minimum of 9+ years’ experience with increasing responsibility in medical device regulatory affairs
- Certification or formal education in medical device regulatory affairs
- Experience with Companion Diagnostics (CDx) is very beneficial and highly desirable
- 3-5 years Regulatory Affairs Experience or equivalent
- Majority of Regulatory Affairs experience in Medical Device industry preferred
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Senior Regulatory Affairs Job Description
Job Description Example
Our growing company is looking for a senior regulatory affairs. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for senior regulatory affairs
- Collaborate with International Regulatory Affairs and other appropriate key stakeholders to determine the impact of proposed manufacturing, packaging, labeling or design changes on current and pending registrations outside the United States (CFDA, US, CE, Health Canada,, TGA)
- Providing advice and guidance, in an expert capacity, to the AWM GBU RA staff
- Liaising with external regulatory authorities to ensure approvals are obtained in line with the launch plan
- Reviewing and approving artwork, labelling and promotional literature from UK / Group Companies based on acceptability/compliance with regulations/compliance with registered details and in compliance with the Blue Guide advise on its acceptability/compliance with regulations and registered details
- Maintaining marketing authorisations to account for changes in the product or national legislation requirements and licence renewals
- Reviewing and approving change control impact assessments for products
- Responsible for developing and implementing global regulatory strategy and roadmaps through deep
- Provide management and leadership to the Regulatory Affairs organization in the development and implementation of regulatory strategies and processes to gain product approvals worldwide
- Responsible for keeping management team informed of regulatory status of products and significant regulatory issues
- Represent the Company before regulatory authorities
Qualifications for senior regulatory affairs
- Travel time required, up to 5%
- Bachelor degree in a life sciences field required
- Advanced degree in a technical field preferred
- 8+ years experience in specific role of Regulatory Affairs Leader and Manager within the IVD industry
- 15+ total years Regulatory Affairs experience, preferably within the IVD/medical device industry, and molecular diagnostics
- Knowledge and experience with CLIA lab requirements a plus