Regulatory Consultant (LS-220227)
Start Date: ASAP
Location: San Diego, CA
Duration: 3+ months
Pay Rate: DOE
Type: Contract
Job Description

Looking for a Regulatory expertise to answer questions in format that is acceptable to the FDA / CDRH



Skills
  • Client is looking to submit 510(k) for additional products that are classified as Class II, IVD (In Vitro Diagnostic devices) test kits
  • The work can be performed remotely for the duration of the assignment


Experience:
  • 10+ years of Regulatory Affairs experience
  • Medical device (specifically IVD) experience
  • Extensive experience with submissions of 510(k) / Premarket notifications
  • Experience and understanding of immune assays
  • Need to have experience with responding to and communicating with notified bodies regarding submissions

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