Connecting...

Senior Manager of Regulatory Affairs

A global Medical Device manufacturing company is searching for a Senior Manager of Regulatory Affairs to join their expanding team.

Responsibilities:

- Develop regulatory strategy to eliminate regulatory issues amongst cross functional teams/departments

- Aid in regulatory team expansion (hiring, on-boarding, mentoring)

- Monitor all international/domestic regulatory requirement changes and keep essential teams updated

- Represent company as primary contact to FDA and international regulatory authorities

- Lead/oversee the preparation and ultimate submission of all regulatory documents; Class II/III devices ~ IDEs, INDs, 510(k)s, NDAs, ANDAs

Qualifications:

- 8+ years experience in Regulatory Affairs within the Medical Device industry

- 3+ years experience in managing Regulatory Affairs team members

- B.S. in Life Science; M.S./PhD preferential

- Class II device experience required, Class III device experience preferential

- Proven track record of leading regulatory submissions through clearance/approval

Sthree US is acting as an Employment Agency in relation to this vacancy.