Global Regulatory Strategy Lead - Medical Devices

Bracco Medical Technologies; Eden Prairie (MN); On-site; USD 159,000 - 172,000; Full time

Job summary

Bracco Medical Technologies is seeking a senior regulatory leader to independently develop and drive global regulatory strategies for new products and lifecycle programs. You will align cross-functional teams, plan submissions, and manage regulator interactions across FDA, EU MDR, and international markets.

The role emphasizes strategic guidance, risk assessment, and proactive engagement with Notified Bodies, health authorities, and internal stakeholders to ensure compliant and timely product

Qualifications

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

Responsibilities

• Develop, align, execute, and defend complex global regulatory strategies for new products and lifecycle programs.
• Lead complex global regulatory submission programs and manage documentation, milestones, and cross-functional coordination.
• Engage with regulatory authorities, including FDA Q-Submissions, Submissions, and health authority meetings; respond to observations.

Skills

Regulatory strategy

Cross-functional leadership

Regulatory submissions

Risk management

Regulatory compliance

Technical communication

Education

Bachelor’s degree

Advanced degree preferred

Job description

Bracco Medical Technologies is seeking a senior regulatory leader to independently develop and drive global regulatory strategies for new products and lifecycle programs. You will align cross-functional teams, plan submissions, and manage regulator interactions across FDA, EU MDR, and international markets.

The role emphasizes strategic guidance, risk assessment, and proactive engagement with Notified Bodies, health authorities, and internal stakeholders to ensure compliant and timely product