Program Manager Field Actions

Job Summary

Collaborating with cross-functional teams, the full-time Program Manager Field Actions will oversee the planning, coordination, and reporting of medical device field actions, ensuring compliance with global regulatory requirements in a remote capacity.

Key responsibilities

• Serve as a subject matter expert on US FDA regulations and the Getinge Global Field Action process, collaborating with business area partners
• Coordinate the planning and initiation of field actions, ensuring timely reporting and compliance with regulatory guidelines
• Maintain comprehensive records of field actions and facilitate communication with internal and external stakeholders regarding status and compliance risks

Required qualifications

• Bachelor's degree in a scientific or technical discipline; advanced degree preferred
• Minimum of 6 years of experience in Quality, Regulatory Affairs, or Regulatory Compliance within medical devices or pharmaceuticals
• Three or more years of experience with field actions or leading post-market quality projects
• Program Management experience in a Quality function
• Advanced knowledge of Quality Management System operations and relevant regulations and standards