Global Regulatory Strategy Lead, Medical Devices

Bracco Diagnostics Inc.; Eden Prairie (MN); On-site; USD 132,000 - 160,000; Full time

Benefits offered by this job

Health benefits

Paid time off

Retirement savings

Tuition reimbursement

Professional development opportunities

Job summary

Bracco Medical Technologies seeks a Principal Regulatory Affairs Specialist in Eden Prairie, Minnesota to develop and implement regulatory strategies for medical devices across global markets. The role involves leading 510(k) and EU MDR submissions, coordinating multi-disciplinary teams, and representing regulatory during FDA meetings and audits.

The candidate will mentor junior staff and leverage AI tools to improve regulatory deliverables while ensuring compliance with company policies and

Qualifications

• Bachelor’s degree plus 7+ years in medical device Regulatory Affairs.
• Experience with 510(k), EU CE Marking, and Health Canada submissions.
• Experience leading FDA meetings (pre-submissions, submission issue requests).

Responsibilities

• Develop and execute regulatory plans for 510(k) and international submissions.
• Coordinate cross-functional support for worldwide registrations.
• Represent regulatory in project teams and with regulatory authorities; prepare for audits.

Skills

Regulatory Affairs

FDA meetings

Technical writing

AI tools

Education

Bachelor’s degree in science/engineering

RAC Certification (preferred)

Tools

Microsoft 365 Copilot

Regulatory databases

Job description

Bracco Medical Technologies seeks a Principal Regulatory Affairs Specialist in Eden Prairie, Minnesota to develop and implement regulatory strategies for medical devices across global markets. The role involves leading 510(k) and EU MDR submissions, coordinating multi-disciplinary teams, and representing regulatory during FDA meetings and audits.

The candidate will mentor junior staff and leverage AI tools to improve regulatory deliverables while ensuring compliance with company policies and