Senior Regulatory Affairs Specialist


San Diego, CA

Industry: Medical Devices & Diagnostics


5 - 7 years

Posted 285 days ago

This job is no longer available.

 My client a cutting edge complex medical device company with breakthrough technology is seeking a Senior Regulatory Affairs Specialist to add to their team. This position is based in Southern California. 

If you have:


  • 6years of experience in medical devices, 3+ years of regulatory work (submission preparation and advising project teams)
  • Must have demonstrated success with FDA submissions, preferably 510K(s) working with complex devices- 60601 requirements
  • Minimally invasive or implantable device knowledge will be helpful, biocompatibility and sterility experience is also a plus
  • European work experience, tech files or dossier experience is also valuable and expected
  • Since there will be multiple projects going on, someone with the ability to sit on a project team and function independently is highly desirable
  • Cardiology, respiratory and or capital equipment experience is a plus


Company offers:

?        Anticipation of another510K clearance late summer of this year

?        Employee stock, everyone is a shareholder!

?        Local candidates preferred

?        Base + Bonus

$80K - $120K
$80K - $120K base, Equity bonus