Global Regulatory Affairs Leader, Medical Devices

Acist Medical Systems Inc.; Eden Prairie (MN); On-site; USD 159,000 - 172,000; Full time

Benefits offered by this job

Health benefits

Paid time off

Retirement savings

Tuition reimbursement

Professional development opportunities

Job summary

Bracco Medical Technologies is seeking a Sr. Principal Regulatory Affairs Specialist to independently develop and execute global regulatory strategies for complex products and lifecycle programs.

You will lead submissions, engage with FDA and Notified Bodies, and mentor teams to ensure compliant, high-quality deliverables. The role requires extensive experience in regulatory affairs for medical devices, with strong leadership and strategic collaboration across cross-functional teams, and

Qualifications

• Bachelor’s degree plus 15 years of progressively responsible regulatory experience, including 10+ years in medical-device industry.
• Strong knowledge of ISO, GMP, FDA, EU MDR/MDD, and international regulations.
• Experience with FDA 510(k)/PMA, EU CE Mark, Health Canada, and international submissions.

Responsibilities

• Independently develop, align, and defend complex global regulatory strategies for products and lifecycle programs.
• Lead complex global regulatory submission programs, including planning, authoring, and responses with authorities.
• Lead FDA Q-Submissions and Pre-Submissions, and prepare meeting packages.
• Oversee audits and inspections with regulators and Notified Bodies.
• Mentor Regulatory Affairs staff and drive process improvements using digital tools.

Skills

Regulatory strategy

Global regulatory submissions

FDA Q-Submissions

Regulatory authority meetings

Regulatory leadership

Education

Bachelor’s degree

RAC Certification

Tools

Quality systems regulations

Job description

Bracco Medical Technologies is seeking a Sr. Principal Regulatory Affairs Specialist to independently develop and execute global regulatory strategies for complex products and lifecycle programs.

You will lead submissions, engage with FDA and Notified Bodies, and mentor teams to ensure compliant, high-quality deliverables. The role requires extensive experience in regulatory affairs for medical devices, with strong leadership and strategic collaboration across cross-functional teams, and