Summary: A Global leader in medical device technology is currently seeking a driven, and motivated Senior Regulatory Affairs Specialist to join their team in the greater Boston area. You will play a key role in helping push the frontier in medical device technology, and help create a more sustainable future for the medical device industry and society. In addition to that, you will be able to make a direct impact on the firm by immediately helping grow their regulatory team. Do you find yourself to be motivated, passionate, and eager about regulatory affairs? If yes, please reach out to learn more.
The Senior Regulatory Affairs Specialist will be responsible for…
- Preparing and submitting global regulatory applications, including:
- S Medical submissions (510ks, IDEs, Pre-submissions)
- Canadian Class 3 Device license submissions
- EU MDR Submissions
- Other international markets (Japan, Saudi Arabia, Australia, Brazil)
- Asses design and manufacturing changes for compliance with applicable regulations
- Supporting post-market surveillance, including post-market clinical follow up plans and reports
- Submitting medical device reports, as well as supporting unique identifier activities
- Supporting quality system audits by notified bodies, government agencies and customers
The Senior Regulatory Affairs Specialist should have the following qualifications:
- Bachelor's degree or equivalent in an engineering or life science discipline
- 2-5 years of experience in regulatory affairs, with experience with submissions and management of class II electro-mechanical devices
- Knowledge of design controls and risk management practices, as well as knowledge of regulations and standards (FDA QSR's, ISO 13485, ISO 14971, IEC 60601, 60825, and 62366)
- Strong working knowledge of Microsoft Word and Excel
Are you interested in working with a world leader in medical device technology? Follow the link and don't wait to apply!
