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Regulatory Affairs Specialist

Background:

Two Regulatory Affairs Specialist positions with local medical device company in Carlsbad.

Responsibilities:

  • Maintain regulatory compliance with ISO 13485, and 21 CFR 820
  • Assist in developing regulatory strategy
  • Act as regulatory representative in new product groups.
  • Technical file management
  • Product development life cycle management in regulatory capacity


Requirements:

  • BS in science or engineering related field
  • 2-5 years of experience in medical device, or related environment
  • Medical device, biotech, or pharmaceutical experience
  • new product development experience
  • 21 CFR 820

Sthree US is acting as an Employment Business in relation to this vacancy.