Regulatory Affairs Consultant

Found in: Appcast Linkedin GBL C2 - 2 weeks ago

Mansfield, United States Oxenham Group Full time

Title: Regulatory Affairs Consultant

Duration: 24 months

Location: Remote

Pay: $45-55/hr

**No C2C or sponsorship available**

Requirements:

  • 3+ years of experience in Regulatory Affairs
  • 3+ years of EU MDR experience - reviewing and filing tech files
  • Experience with Class I, II, and III devices

SUMMARY DESCRIPTION

  • Independently provide EU regulatory requirements and guidance to EU MDR project teams.
  • Lead the preparation of the EU MDR technical documentation for Class III, IIa, IIb, or Class I sterile or reusable medical devices to support timelines for CE marking and EU commercial release.
  • Lead the submittal of the EU MDR technical documentation for Class III, IIa, or IIb medical devices and collaborate with the cross-functional team and Notified Body to respond to any questions during the review.

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