Vice President, Regulatory Affairs

The Global Head of Regulatory Affairs is responsible for establishing and executing the worldwide regulatory strategy across the Company's medical device portfolio, including new product development, global registrations, lifecycle management, market expansion, and post-market compliance activities.

As the Company's senior-most regulatory leader, this role serves as a strategic business partner to the Global Head of Science & Technology and the broader CooperSurgical leadership team, ensuring regulatory excellence while enabling innovation, accelerating global market access, and supporting enterprise growth objectives. The Global Head of Regulatory Affairs provides leadership for all regulatory activities worldwide and is accountable for building a high-performing organization that delivers predictable regulatory outcomes, proactively manages risk, and drives competitive advantage through regulatory strategy.

This position collaborates extensively with Research & Development, Clinical Affairs, Quality, Medical Affairs, Manufacturing, Supply Chain, Legal, Marketing, Commercial, and Product Management organizations to support the successful development, approval, commercialization, and lifecycle management of the Company's products globally.

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- Regulatory Affairs Certification (RAC) preferred.
- Experience in Women's Health, Fertility, Reproductive Health, Surgical, Diagnostic, or Medical Device markets preferred.
- Experience working within global publicly traded medical device organizations.
- Demonstrated participation in industry associations, regulatory working groups, or standards organizations.
- 15-20+ years of progressive Regulatory Affairs experience within the medical device, diagnostics, or broader life sciences industry.
- 10+ years of leadership experience directing global regulatory organizations and multi-regional teams.
- Demonstrated success developing and executing global regulatory strategies for complex medical device portfolios.
- Significant experience supporting Class II and/or Class III medical devices across multiple markets.
- Extensive experience leading interactions with FDA, Notified Bodies, Competent Authorities, and international regulatory agencies.
- Proven track record of successfully supporting product development, commercialization, acquisitions, and global market expansion initiatives.
- Experience leading organizations through periods of growth, transformation, and regulatory change.

Deep expertise in:
- FDA medical device regulations and regulatory pathways
- 510(k), PMA, De Novo, IDE, and global submission processes
- EU MDR and IVDR requirements
- ISO 13485 Quality Management Systems
- ISO 14971 Risk Management
- MDSAP requirements
- Clinical evaluation and performance evaluation requirements
- Post-market surveillance and vigilance programs
- Labeling and promotional compliance
- Global medical device registration and market access requirements

Education:
- Bachelor's degree in Engineering, Biomedical Engineering, Life Sciences, Regulatory Affairs, Pharmacy, or a related scientific discipline required.
- Advanced degree strongly preferred (MS, PhD, MBA, PharmD, JD, or equivalent).

As an employee of CooperSurgical, you will receive a competitive total compensation plan. Your recruitment team will be able to share more information about any variable pay opportunity and benefit package that accompanies this role. The good faith estimate of the salary range for this role is $220,000 to $350,000 per year. The actual amount offered is determined by a number of factors including but not limited to location, skills and experience.

To all agencies: Please, no phone calls or emails to any employee of CooperSurgical about this opening. All resumes submitted by search firms/employment agencies to any employee at CooperSurgical via-email, the internet or in any form and/or method will be deemed the sole property of CooperSurgical, unless such search firms/employment agencies were engaged by CooperSurgical for this position and a valid agreement with CooperSurgical is in place. In the event a candidate who was submitted outside of the CooperSurgical agency engagement process is hired, no fee or payment of any kind will be paid.

We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. We are proud to be an equal opportunity workplace. If you are interested in applying and require special assistance or accommodations due to a disability, please contact us at [email protected].