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Regulatory Affairs Specialist

2 months ago

Irvine, California, United States Tucker Parker Smith Group (TPS Group) Full time
Regulatory Affairs Specialist II

Location: Irvine, CA (Hybrid 3 days on site)

12 month Assignment

Pay Rate: $45-$49/hr.

We are seeking a Regulatory Affairs Specialist to support the EU's In Vitro Diagnostic Regulation (IVDR) transition activities for a medical device client. The successful candidate will be responsible for revising technical files, attending weekly meetings, and supporting labeling conversion projects.

Key Responsibilities:

  • Revised technical files using the latest template and ensured clear presentation of product characteristics and expected performance.
  • Attended multiple weekly meetings to address issues and questions regarding technical files and kept the project manager informed on progress.
  • Supported labeling conversion projects, including cross-functional participation and weekly group meetings.
  • Updated labeling conversion tracking log based on manufacturing schedule, product fill dates, and change requests numbers.
  • Un-CE Marked selected products and tracked work until final labeling reflected desired changes.
  • Updated technical file tracking log, notified RA Regional notifications of labeling changes, and notified RA SAP restriction coordinator when specific product lots needed restriction.

Requirements:

  • Bachelor's degree in biochemistry, biology, medical technology, or related fields and 3+ years of experience in RA, QA, R&D, Manufacturing, or Project Management in the IVD industry.
  • Knowledge of FDA and CE marking requirements for IVD products was a plus.
  • Thorough knowledge of policies, practices, and procedures related to RA.

Please submit a copy of your resume in Word or PDF format to be considered.