Program Manager for Field Actions

Job Summary

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

Key Responsibilities

• Serve as the point of contact for Cardiovascular field action activities and provide work direction to junior staff
• Plan customer notifications and reports for medical device field actions, ensuring compliance with strict timelines
• Prepare and submit progress reports to regulatory authorities and manage customer responses and product returns

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 medical devices or pharmaceuticals in Quality, Regulatory Affairs, or Compliance roles
• 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