Regulatory Affairs Professional 3

  • Location

    Newark, United States

  • Sector:

    Business Professional

  • Job type:


  • Contact:

    Sonu Chouhan

  • Job ref:


  • Published:

    about 1 year ago

  • Expiry date:


  • Maintain technical files for in vitro diagnostic products in compliance with European In Vitro Diagnostics Directive 98/79/EC (IVDD) and IVDR
  • Prepare and review technical file submissions for reagents, calibrators, controls and verifiers against relevant standards.
  • Provide regulatory review of the claims and technical files to maintain EU CE marking.
  • Investigate and close GAPs in documentation for technical files.
  • Support e-filing by reviewing and logging files to be uploaded into Documentum.
  • Upload and QC files in Documentum.
  • Experience with SAP.
  • Education requirements: Bachelors of Art/Science in a Science related field
  • Regulatory Affairs Experience Preferred.