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