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Regulatory Affairs Professional 3

  • Location

    Newark, United States

  • Sector:

    Business Professional

  • Job type:

    Contract

  • Contact:

    Sonu Chouhan

  • Job ref:

    21823

  • Published:

    12 months ago

  • Expiry date:

    2020-10-28

  • Analyzes the requirements and prepares product related regulatory submissions for IVDR.
  • Provide regulatory review of the claims and technical files to maintain EU CE marking

in compliance with European In Vitro Diagnostics Directive 98/79/EC (IVDD) and IVDR

  • Creates quality guidelines and work instructions relevant for maintaining regulatory compliance.
  • Investigate and close GAPs in documentation for technical files.
  • Troubleshoots and analyzes categorization, intended purpose and other IVDR topics
  • Initiates and escalates necessary activities if deviations are identified.
  • Ensures creation of adequate documentation for related audits/inspections.
  • 5-8 years Deep professional know-how and experience in Regulatory affairs (preferably IVD products). Solid professional judgment and problem solving competence. Improves existing processes and approaches.