Freelance Regulatory Writer - Medical Devices

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