Global Regulatory Strategy Lead — Medical Devices

Bracco Medical Technologies; Eden Prairie (MN); Vor Ort; USD 159.000 - 172.000; Vollzeit

Benefits dieser Stelle

Health benefits

Paid time off

Company holidays

Paid family leave

Retirement savings

Tuition reimbursement

Professional development

Zusammenfassung

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

This senior expert collaborates with project teams and leadership to align stakeholders around regulatory paths that enable market access. The role leads global regulatory submissions, interactions with FDA and Notified Bodies, and utilizes digital and AI tools to improve deliverables while

Qualifikationen

• Bachelor's degree plus 15 years of regulatory experience in the medical-device industry.
• Strong knowledge of quality systems regulations, ISO, GMP, FDA, EU MDR, and international requirements.
• Experience with FDA 510(k) or PMA, EU CE Mark submissions, Health Canada, and international registrations.
• Excellent written, verbal, technical writing, and presentation skills at all levels.
• Proven ability to lead complex global regulatory projects and align cross-functional teams.

Aufgaben

• Develop and defend complex global regulatory strategies for new products, changes, and lifecycle programs.
• Lead complex regulatory submissions: planning, documentation, and cross-functional coordination.
• Lead FDA Q-Submissions/Pre-Submissions and health authority meetings; prepare meeting packages.
• Drive regulatory excellence and continuous improvement using approved AI tools.
• Mentor Regulatory Affairs staff and support mergers, acquisitions, and integration activities.
• Maintain relationships with authorities, Notified Bodies, and external reviewers.

Kenntnisse

Regulatory strategy

FDA submissions

Notified Bodies interaction

Cross-functional leadership

Regulatory risk management

Quality systems knowledge

Technical writing

Public speaking/presentation

Project leadership

AI-enabled regulatory workflows

Ausbildung

Bachelor's degree in a relevant field

RAC Certification

Advanced degree in Science/Engineering

Jobbeschreibung

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

This senior expert collaborates with project teams and leadership to align stakeholders around regulatory paths that enable market access. The role leads global regulatory submissions, interactions with FDA and Notified Bodies, and utilizes digital and AI tools to improve deliverables while