I am currently sourcing for several regulatory opportunities at medical device companies in the Southern LA region (from Anaheim to Lake Forest) in addition to building a pipeline for February and March after my clients get headcount and budget for new hires.
The roles I am actively working on are in the located in South LA in the Irvine/OC area at the Senior Specialist/Manager level. These range from large established companies to smaller start-ups and from class I - class III with a salary ranging between 100-130k depending on experience and the company.
These Regulatory Affairs professionals need to have exposure (authorship is a plus) to technical files, international submissions, 510(k)s, and/or PMA/IDEs.
Their experience should also include but is not limited to:
- Interactions with notified bodies
- Maintaining device listings and registrations is US, Canada, and EU
- Up-to-date knowledge of domestic and international regulatory requirements
- Pre and post market regulatory work
- Cross collaboration with other departments (marketing, quality, engineering)
Additional quality experience is also desirable for some clients which includes:
- Experience with internal, external, and 3rd party audits
- Full- cycle CAPA management
- Knowledge of ISO 13485 and 14971
If this sounds in-line for your background and what you want next career move to be, please reply to this ad with your updated resume and the best number to reach you at. I will be qualifying applicants for phone screening slots next week.
Sthree US is acting as an Employment Agency in relation to this vacancy.