Regulatory Affairs Specialist

Location: Irvine Salary: competitive
Sector: Medical Devices, Quality Assurance (QA), Regulatory Affairs (RA) Type: Contract


A large medical device manufacturer is looking for some help in the regulatory affairs department. The position will be focused on 510k's, and post approvals.


This individual will be working hands on to accomplish all duties related to 510k submissions, and post market approval's. Specifically this company works heavily with Class II medical devices so experience in these areas is a huge plus. Other areas that this specialist would be working with labeling, registrations and other domestic regulatory affairs activities. This individual will also be doing some work with international regulatory activities.


- Class II device experience

- 510k submission experience

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