Program Manager - Medical Devices

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

Apr 4, 2025 - 17:13

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