Remote Government Regulatory Affairs Associate

This job has been removed
Location: Nationwide
Compensation: To Be Discussed
Staff Reviewed: Tue, Jul 26, 2022
This job expires in: 7 days
Job Summary

A clinical and scientific staffing company has an open position for a Remote Government Regulatory Affairs Associate.

Candidates will be responsible for the following:

  • Filing necessary applications
  • Reviewing and approving manufacturing changes for Class III implantable medical devices
  • Reviewing/approving engineering study protocols/reports and validation study protocols/reports

Required Skills:

  • Knowledge of FDA PMA guidance documents and CFR regulations
  • Recent experience with Class III implantable medical devices
  • Relies on extensive experience and judgment to plan and accomplish goals
  • May require an advanced degree and 5-8 years of direct experience in the field
  • Proven successful track record of authoring/submission/approval of Class III implantable PMA supplements
COMPLETE JOB DESCRIPTION

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