Description
A fast-growing medical device start-up is seeking a Director of Regulatory Affairs. With both commercial products and technology in development, the Regulatory Affairs Director will lead the strategy and submission of new products and product changes to global health agencies.The Regulatory Affairs Director will:
- Develop and implement regulatory strategies for new and existing products.
- Recommends, interprets and implements policies and procedures to accomplish assignments and resolves a broad range of issues and problems.
- Manages subordinates responsible for regulatory submissions
- Participate on prouct development core teams as regulatory affairs representative
- Write, review and prepare regulatory submissions (IDE, 510k, PMA) for FDA clearance/approval.
Qualifications:
- 6 or more years of regulatory affairs experience
- 10 or more years experience in medical device industry
- Experience with FDA 510(k) and PMA submissions/strategy
- Experience with EU and other international submissions/strategy
- B.S. (scientific field a plus)
To find out more about Real please visit www.realstaffing.com