Vice President, Regulatory Affairs

About the role

The Global Head of Regulatory Affairs leads the worldwide regulatory strategy for CooperSurgical’s medical device portfolio, ensuring compliance, accelerating market access, and supporting enterprise growth. This senior leader partners with executive teams across R&D, Quality, Clinical, and Commercial functions.

Key responsibilities

• Develop and execute global regulatory strategy for devices, software-enabled solutions, and emerging technology platforms.
• Lead global registration, submission, approval, and maintenance activities across FDA, EU MDR, UKCA, Health Canada, PMDA, NMPA, ANVISA, TGA, MDSAP, and other authorities.
• Provide regulatory leadership throughout product development, from concept to lifecycle management, integrating regulatory requirements into design controls and risk management.
• Represent the company with regulatory agencies, lead inspections, and negotiate with authorities.
• Build and mentor a high‑performing global Regulatory Affairs organization, managing budgets, performance metrics, and talent development.

Required profile

• Senior executive with extensive experience in global medical device regulatory affairs.
• Proven ability to influence senior leadership and drive strategic regulatory decisions.
• Strong business acumen, commercial mindset, and executive presence.

Required skills

• FDA regulatory processes
• EU MDR and IVDR compliance
• UKCA requirements
• Health Canada regulations
• PMDA (Japan) regulations
• NMPA (China) regulations
• ANVISA (Brazil) regulations
• TGA (Australia) regulations
• MDSAP standards