Freelance Regulatory Writer - Medical Devices
Overview
We are supporting a leading medical device organisation seeking an experienced Freelance Regulatory Writer - Medical Devices with strong FDA submissions expertise to support ongoing regulatory documentation activities across the device portfolio.
Key Responsibilities
- Author, review, and finalise FDA submissions including 510(k), De Novo, PMA, and IDE
- Prepare pre-submission (Q-Sub) documentation and support FDA meeting preparation
- Develop clinical and technical sections of FDA submissions, including substantial equivalence rationales
- Author and maintain Investigator Brochures, Clinical Study Reports (CSRs), and Clinical Evaluation documentation to support US filings
- Prepare responses to FDA deficiency letters, AI requests, and Additional Information (AI) responses
- Author and maintain Instructions for Use (IFU), labelling, and product information in line with FDA requirements (21 CFR 801)
- Support post-market documentation, including MDRs and post-market study reports
- Ensure compliance with FDA 21 CFR Part 820 (QSR), Part 807, and Part 812
- Collaborate cross-functionally with Regulatory Affairs, Clinical, Quality, and R&D teams
- Support global submissions where required (Health Canada, MHRA, EU MDR - secondary)
Requirements
- Proven experience as a Regulatory Writer in the medical device industry
- Strong, demonstrable experience with FDA submissions - specifically 510(k), De Novo, PMA
- Familiarity with FDA guidance documents and CDRH expectations
- Knowledge of:
- 21 CFR Part 820, 807, 812
- ISO 13485, ISO 14971
- Substantial equivalence methodology
- Experience across Class I-III medical devices
- Strong scientific/technical writing background
- Ability to work independently in a freelance/contract environment
Desirable
- Experience supporting FDA pre-submission (Q-Sub) meetings
- Background in clinical or scientific writing
- Experience with combination products, IVDs, or SaMD
- Familiarity with eCopy / eSTAR submission formats
FAQs
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