Remote Medical Device Regulatory Affairs Specialist

Location: Nationwide

Compensation: To Be Discussed

Staff Reviewed: Mon, Nov 08, 2021

This job expires in: 11 days

Job Category: Healthcare

Remote Level: 100% Remote

Employer Type: Employer

Career Level: Experienced

Education Level: Bachelors

Job Summary

A contract research organization needs applicants for an opening for a Remote Medical Device Regulatory Affairs Specialist.

Individual must be able to fulfill the following responsibilities:

  • Support implementation and execution of CDX strategy
  • Provide guidance to the teams on the regulatory requirements
  • Collaborate with lab partners to mutually align on co-development regulatory needs

Qualifications Include:

  • 1+ years’ regulatory experience in medical devices with at least 1-2 years in IVDs
  • Must have experience with medical device submissions including pre-submissions, IDEs, 510(k)s
  • Ability to develop/review new regulatory policies, processes and SOPs

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