Senior Regulatory Affairs Specialist

Confidential Company  •  San Diego, CA

5 - 7 years experience  •  Medical Devices & Diagnostics

$80K - $120K ($80K - $120K base, Equity)
Posted on 03/09/18
Confidential Company
San Diego, CA
5 - 7 years experience
Medical Devices & Diagnostics
$80K - $120K
($80K - $120K base, Equity)
Posted on 03/09/18

 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

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