Peterborough, United States
4 months ago
Regulatory Affairs Manager
- Develop regulatory strategies to support operational objectives for US and international marketing and sale.
- Review new and modified devices for fulfillment of regulatory obligations: FDA, European MDD/MDR, CE, PMDA, and Canadian CMDR.
- Review new and modified devices for fulfillment of appropriate standards for electrical, mechanical, material and software safety: ISO, UL, IEC.
- Prepare regulatory documents required for timely completion of regulatory submissions that could include some or all of the following: pre-submissions, PMA, 510(k), IDE and technical file for Notified Body.
- Maintain appropriate domestic and international registrations and product listings.
- Support post-market corrective actions.
- Bachelor’s Degree – preferably in Life Sciences or Engineering disciplines
- Minimum 5 years medical device industry experience in a regulatory affairs role
- Thorough understanding of medical device agency regulations: FDA’s medical device regulation (21 CFR Part 820), CE, European MDD/MDR, PMDA, CMDR
- Working knowledge of applicable medical device standards. E.g.: ISO 13485, ISO 14971, IEC 60601, IEC 62304.
- Experience developing successful regulatory strategies.
- Experience interfacing directly with the FDA, international regulatory agencies and notified bodies.