Program Manager - Medical Devices

Job is Expired
Location: Remote
Compensation: Salary
Reviewed: Fri, Apr 04, 2025
Program Management ISO Standards Regulatory Compliance FDA Audits

Job Summary

A company is looking for a Program Manager CS (Remote US) - Defined Term.

Key Responsibilities
  • Serve as the point of contact for Cardiovascular field action activities and provide direction to junior staff
  • Collaborate with stakeholders to manage customer notifications and reports for medical device field actions
  • Prepare and submit progress reports to regulatory authorities and maintain documentation for field actions
Required Qualifications
  • Bachelor's degree in a scientific or technical discipline or equivalent work experience; advanced degree preferred
  • Minimum of 6 years of experience in Quality, Regulatory Affairs, or Regulatory Compliance roles within medical devices or pharmaceuticals
  • Three or more years of experience with field actions and/or complaints and vigilance preferred
  • Program Management experience in a Quality function and advanced knowledge of Quality Management System operations
  • Experience with FDA and/or Notified Body audits/inspections
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