Principal Regulatory Affairs Specialist - Bracco Medical Technologies

Bracco•Eden Prairie, MN

About The Position

The Principal Regulatory Affairs Specialist develops and executes regulatory strategies for medical device products, submissions, and lifecycle changes. This role provides hands-on regulatory support for new product marketing submissions, changes to existing devices, global registrations, audits, labeling, and ongoing compliance with applicable regulations and company standards.

Requirements

Bachelor’s degree in Engineering, Life Sciences, Regulatory Affairs, or a related technical field.
7+ years of regulatory affairs experience in the medical device industry.
Demonstrated experience preparing and supporting global regulatory submissions, including FDA 510(k), EU MDR/CE Marking, and Health Canada submissions.
Strong understanding of FDA regulations, EU MDR, international regulatory frameworks, product lifecycle requirements, labeling review, and regulatory compliance practices.
Experience leading or supporting FDA meetings, agency interactions, audits, inspections, and cross-functional regulatory strategy discussions.
Excellent technical writing, communication, project leadership, analytical thinking, and stakeholder management skills.

Nice To Haves

Experience supporting Class II medical devices, global market expansion, or multi-region regulatory submissions.
Experience mentoring regulatory professionals or leading regulatory workstreams without direct supervisory authority.
Regulatory Affairs Certification or advanced degree in a relevant discipline.

Responsibilities

Develop and execute regulatory plans for product submissions, including 510(k) Premarket Notifications, EU MDR Technical Documentation, Canadian Licensing Submissions, and select Japan/China submission content.
Serve as the regulatory representative on cross-functional project teams throughout the product lifecycle, providing strategic guidance on global regulatory requirements.
Prepare for and support communications with regulatory agencies and Notified Bodies, including FDA interactions, submission reviews, approvals, audits, and inspections.
Maintain complete and current regulatory files, product registrations, and supporting documentation.
Review device labeling, advertising, and promotional materials for compliance with approved submissions and applicable global regulations.
Monitor new and changing regulations, assess business impact, and recommend appropriate compliance actions.
Mentor junior regulatory staff and provide regulatory guidance to cross-functional partners.