Regulatory Affairs Specialist

San Diego, California

Work Arrangement: Hybrid
2022-05-05

Regulatory Affairs Specialist:
Are you looking for an exciting role within the San Diego area as a Regulatory Specialist?  This role is working for a top medical device company in Sorrento Valley. You will be responsible for the independent preparation and maintenance of domestic and international regulatory filings to meet corporate objectives.  Apply today! 

Who You Are:
 

  • Bachelor’s degree or equivalent combination of education and applicable job experience
  • Master’s degree preferred
  • Seeking candidate with 2 years FDA experience within a Medical Device industry,

What You'll Do:

  • Skilled with MS Office applications, Adobe Acrobat, document control applications, and other computer-based applications.
  • Demonstrated knowledge of 21 CFR 814, 21 CFR 820, and other FDA guidance.
  • Provides regulatory affairs support for all aspects of product development and manufacturing.
  • Reviews and approves document change orders and determines regulatory strategies for each change.
  • Prepares letters-to-file as needed for change orders that require them.
  • Prepares regulatory submissions for new product clearances/approvals including PMAs, 510(k)s, dossiers, technical files, etc.

 

We actively support and promote people of various backgrounds, from race, religion and gender to geographical area, university, lifestyle and personality type. Proven Recruiting is minority-owned, majority women, and is a strong advocate for diversity and inclusion in the broader community. Apply now!

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