Regulatory Affairs Professional 3

  • Location

    Tarrytown, United States

  • Sector:

    Business Professional

  • Job type:


  • Contact:

    Sonu Chouhan

  • Job ref:


  • Published:

    10 months ago

  • Expiry date:


This is a one year project.


  • 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).
  • SAP knowledge and hands-on experience
  • Experience with medical device labeling review.
  • Regulatory Affairs experience with in vitro diagnostics.
  • Proficiency with Windows 10 and Microsoft Office 365.
  • Ability to work with cross-functional team to collect data for UDI and updating in SAP

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

  • Gather regulatory and product information to support upload of this information to

SAP to support EU UDI.

  • Identify and close gaps
  • 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.