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Regulatory Affairs Specialist

2 months ago

Irvine, California, United States Tucker Parker Smith Group (TPS Group) Full time
Job Summary

We are seeking a highly skilled Regulatory Affairs Specialist to support our client's transition to the EU's In Vitro Diagnostic Regulation (IVDR). The successful candidate will play a key role in revising technical files, attending project meetings, and ensuring compliance with regulatory requirements.

Key Responsibilities
  • Technical File Revisions: Revise assigned technical files to ensure compliance with the latest IVDR requirements.
  • Project Meetings: Attend weekly meetings to address issues, provide updates, and ensure project progress.
  • Labeling Conversion: Support the IVDR labeling conversion project, participating in cross-functional meetings and tracking progress.
  • Labeling Updates: Update labeling specifications to meet IVDR requirements and track changes.
  • Product Restriction: Support tasks to un-CE Mark selected products and track work until final labeling reflects desired changes.
  • Additional Responsibilities: Update technical file tracking logs, notify RA Regional notifications of labeling changes, and notify the RA SAP restriction coordinator as needed.
Requirements
  • Education: Bachelor's degree in biochemistry, biology, medical technology, or related field.
  • Experience: 3+ years of experience in RA, QA, R&D, Manufacturing, or Project Management in the IVD industry.
  • Knowledge: Thorough knowledge of FDA and CE marking requirements for IVD products.
What We Offer

Tucker Parker Smith Group (TPS Group) offers a dynamic and challenging work environment. If you are a motivated and detail-oriented individual with a passion for regulatory affairs, we encourage you to apply.