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Regulatory Affairs Professional 2

  • Location

    Newark, United States

  • Sector:

    Business Professional

  • Job type:

    Contract

  • Contact:

    Sonu Chouhan

  • Job ref:

    22982

  • Published:

    about 2 months ago

  • Expiry date:

    2021-01-30

The candidate can be either in Newark, DE area or Tarrytown, NY. Manager looking for 2-5 years experience

Duties Support the regulatory activities needed to comply with the European In Vitro Diagnostic Regulation (IVDR 2017/746) by performing the following:

  • Regulatory review of technical documentation for reagents, calibrators, controls, and other in vitro diagnostic products to comply with European In Vitro Diagnostic Regulation (2017/746/EU).
  • Gather regulatory documents and information to support creation of technical documentation.
  • Identify and close gaps in technical documentation.
  • Work collaboratively to complete tasks, both within regulatory affairs and with other departments.
  • Create, review, and route for approval EU Declarations of Conformity.
  • Provide periodic progress reports to supervisors.
  • Attend in-person and teleconference meetings as assigned.
  • Prepare finished IVDR technical documentation for submission to the Notified Body.
  • Prepare quality records for electronic archival.

Must Have

  • Education: Bachelor of Art/Science in a Science related field.
  • Regulatory Affairs experience in an industry such as pharmaceuticals, medical devices, or in vitro diagnostics.
  • Proficiency with Windows and Microsoft Office (especially Microsoft Word and Excel).
  • Great time management and organizational skills.

Preferred

  • Experience with and knowledge of (a) the European In Vitro Diagnostics Medical Devices Directive (IVDD 98/79/EC) and/or (b) the European In Vitro Diagnostic Regulation (IVDR 2017/746).
  • Experience with SAP.
  • Experience with medical device labeling review.
  • Regulatory Affairs experience with in vitro diagnostics.
  • Proficiency with Windows 10 and Microsoft Office 365.