Global Regulatory Strategy Lead – Medical Devices

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.