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
? Anticipation of another510K clearance late summer of this year
? Employee stock, everyone is a shareholder!
? Local candidates preferred
? Base + Bonus