Global Regulatory Strategy Lead – Medical Devices

Bracco; Eden Prairie (MN); Hybride; USD 159 000 - 172 000; Plein temps

Avantages offerts par ce poste

Health benefits

Paid time off

Retirement savings

Résumé du poste

Bracco is seeking a Sr. Principal Regulatory Affairs Specialist to independently develop, align, execute, and defend complex global regulatory strategies for new products and lifecycle programs in the medical device space.

The role requires high-level interaction with FDA, Notified Bodies, and cross-functional teams across regions. You will lead global submissions (FDA 510(k)/PMA, EU MDR, Health Canada) and mentor junior staff, while leveraging digital tools to enhance efficiency and quality.

Qualifications

• Bachelor’s degree plus 15 years in regulatory across medical devices.
• Strong experience with FDA 510(k)/PMA, EU CE MDR, and Health Canada.
• Proven ability to lead complex global regulatory submissions.
• Excellent written and verbal communication with cross-functional teams.
• Ability to travel up to 20%.

Responsabilités

• Independently develop, align, execute, and defend complex global regulatory strategies for new products and lifecycle programs.
• Lead complex global regulatory submissions, including planning, documentation, and authority responses.
• Engage with FDA and Notified Bodies; develop meeting packages and respond to feedback.
• Mentor regulatory staff and drive continuous improvement using digital tools.
• Ensure compliance in labeling and advertising materials.
• Support regulatory due diligence for mergers, acquisitions, licensing, and strategic initiatives.

Connaissances

Regulatory strategy

FDA submissions (510(k)/PMA)

EU MDR submissions

Cross-functional leadership

Regulatory affairs mentoring

Formation

Bachelor's degree in a relevant field

Description du poste

Bracco is seeking a Sr. Principal Regulatory Affairs Specialist to independently develop, align, execute, and defend complex global regulatory strategies for new products and lifecycle programs in the medical device space.

The role requires high-level interaction with FDA, Notified Bodies, and cross-functional teams across regions. You will lead global submissions (FDA 510(k)/PMA, EU MDR, Health Canada) and mentor junior staff, while leveraging digital tools to enhance efficiency and quality.