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Principal Regulatory Affairs Specialist

Company: Lumicity
Location: San Jose
Posted on: November 24, 2022

Job Description:

We are looking for a Principal Regulatory Affairs Specialist to join one of our Medical Device Clients in the San Jose area. This individual will be tasked with writing, preparing and supporting regulatory submissions for FDA and other regulatory agencies while providing assistance and guidance for other regulatory strategies.

  • Responsible for writing and maintaining regulatory documents such as 501(k) submissions, risk analysis, design history files, etc.
  • Work cross functionally with engineering and R&D Department and the product development team to make sure that regulatory requirements are met, and regulatory submissions are handled for products in different markets.
  • Represent the regulatory affairs department in FDA site audits.
    • BS Technical or Scientific Discipline, (MS Regulatory Affairs Preferred)
    • 5-10 years of experience in medical device regulatory affairs
    • Experience with EU Regulations, EU MDRs, Medical Device Directives (93/42/EC)
    • Experience writing FDA submissions required (510k, IDE, PMA)
    • ISO 13485:2016 and ISO 14971 Experience

      • Great working culture, flexible hours
      • Working on breakthrough Class II Medical Device
      • Full Benefits, 401k, Generous Bonus Structure

        *Must be a US Citizen or Green Card Holder

Keywords: Lumicity, San Jose , Principal Regulatory Affairs Specialist, Other , San Jose, California

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