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Regulatory Affairs Manager

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.

Responsibilities:

  • 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

Skills:

  • 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.