Global Regulatory Strategy Leader, Medical Devices

CooperSurgical; Trumbull (CT); On-site; USD 220,000 - 350,000; Full time

Job summary

CooperSurgical seeks a strategic Global Head of Regulatory Affairs to shape worldwide regulatory strategy across medical devices, software-enabled solutions, and future platforms. You will partner with executive leadership to accelerate market access, manage lifecycle activities, and drive regulatory excellence across North America, Europe, and beyond.

Leadersh ip responsibilities include building a high‑performing global team, guiding submissions and inspections, and aligning regulatory

Qualifications

• 15-20+ years of progressive Regulatory Affairs experience within the medical device/biotech sector.
• 10+ years of leadership directing global regulatory organizations and multi-regional teams.
• Extensive experience leading interactions with FDA, Notified Bodies, Competent Authorities, and international regulatory agencies.

Responsibilities

• Develop and execute global regulatory strategies for the company’s devices, software, and technologies.
• Lead executive-level engagement with regulators, industry groups, and standards bodies.
• Oversee regulatory submissions, registrations, licenses, renewals, and ongoing compliance across markets.
• Partner with Quality, R&D, and Business Leaders to align regulatory and business objectives.
• Build and develop a high-performing global Regulatory Affairs organization and budget.

Skills

Executive leadership

Regulatory strategy

Global market access

Regulatory submissions

Cross-functional collaboration

Education

Bachelor’s degree in Engineering, Biomedical Engineering, Life Sciences, Regulatory Affairs, Pharmacy, or related discipline

Advanced degree (MS, PhD, MBA, PharmD, JD, or equivalent)

Job description

CooperSurgical seeks a strategic Global Head of Regulatory Affairs to shape worldwide regulatory strategy across medical devices, software-enabled solutions, and future platforms. You will partner with executive leadership to accelerate market access, manage lifecycle activities, and drive regulatory excellence across North America, Europe, and beyond.

Leadersh ip responsibilities include building a high‑performing global team, guiding submissions and inspections, and aligning regulatory