My client, a Class II and Class III implantable medical device company based in the Bay Area, has an immediate need for a Regulatory Affairs Manager. This is an exciting opportunity to join a growing team working with a range of disruptive products in various areas.
- Develop and implement strategies to achieve FDA (and international) approvals of Class II/III device applications
- Prepare and review all regulatory documents; EU, PMA's, IDE's, HDE's and MDR's
- Work closely with product development and engineering teams to guarantee RA requirements are understood and met
- Participate in audits as requires; FDA and ISO for QSR and BIMO compliance
- Bachelor's degree in relative field; Masters or PhD preferable
- 5+ years Regulatory Affairs experience, specifically in the Medical Device industry
- Solid experience and success with regulatory submissions (US and international)
- Strong management and leadership skills
Sthree US is acting as an Employment Agency in relation to this vacancy.