Our client, a medical device company is looking for an experienced Senior Regulatory Affairs Analyst/Manager to join their molecular diagnostic team based in the Bay Area. Reporting directly into the Director of Regulatory Affairs, this is a rare opportunity to work with a renowned company working on next generation devices.
- Develop and implement regulatory strategies for products; including RA support to company project teams and external entities
- Determine and assure product submission requirements are executed and timely
- Facilitate regulatory analysis of pre- and post- market products; including review/approval of design files and technical files
- Develop and foster positive relations with all applicable regulatory authorities
- B.S. in related science
- 4+ years experience in Regulatory Affairs
- Hands-on experience with either PMA or 510(k) submissions
- Direct experience with FDA and international regulatory authorities
Sthree US is acting as an Employment Agency in relation to this vacancy.