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Real Staffing

Senior Regulatory Affairs Specialist

Post Date:Jan 03, 2018Type:Full-Time
Start Date:1/3/2018Salary:£0.00
Location:US-CA-Irvine Job Reference:RE-32741484

Job Description:

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.

Contact Information
Real Staffing
Name: Ian Davis
Ph: +1 619-881-0004

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