Manager of Regulatory Affairs

Location: Irvine, California Salary: competitive
Sector: Regulatory Affairs (RA) Type: Permanent

Are you looking to advance your regulatory career by working at one of the most innovative IVD companies for blood diagnostics?

I'm working on behalf of my client in Orange County that is in need of a full time add-to-staff Manager of Regulatory Affairs that not only has full cycle 510(k) experience, but also has a strong clinical background(Clinical Evaluation Reports ( CERs ) and/or clinical protocol reports). As they need a candidate that can handle not only pre-market regulatory work to achieve a new device approval, but can also liaise between clinical sites and help manage the clinical data that will be collected.

This role offers the following:

  • A base salary in the mid 100s
  • The ability to author a 510(k) for their flagship new product
  • Minimal domestic travel to clinical sites
  • Working with a small on-site regulatory team while helping manage the offsite clinical team
  • Relocation assistance for non-local candidates

If this opportunity would interest yourself or someone in your network please reach out!

Sthree US is acting as an Employment Agency in relation to this vacancy.