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Sr. Principal Regulatory Affairs Specialist - Bracco Medical Technologies

Bracco Medical Technologies • Eden Prairie, MN, US • published 2026-10-07 03:03:12.933612

Description

***Why Join Bracco Medical Technologies?*** We care as much about our employees as we do our patients. Our culture fosters a work environment where employees can thrive, be passionate and have fun along the way. Each member of the Bracco Medical Technologies team has the power to make a difference......every day! The Sr. Principal Regulatory Affairs Specialist is responsible for independently developing, implementing, and defending complex global regulatory strategies across products, programs, and processes. This individual serves as a senior regulatory subject matter expert and strategic partner to project teams and leadership, aligning cross\-functional stakeholders around regulatory strategies that support business objectives and successful market access. This role leads regulatory activities for complex new product development and lifecycle programs, including the preparation and management of global regulatory submissions. The individual serves as a primary BMT representative in interactions with U.S. and international regulatory authorities and Notified Bodies, including independently developing FDA Pre\-Submission strategies and meeting packages, leading regulatory authorit...

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