Vice President, Regulatory Affairs

CooperSurgical, Inc.; Trumbull (CT); Remote; USD 250,000 - 350,000; Full time

Job summary

CooperSurgical, Inc. is seeking a Global Head of Regulatory Affairs to lead worldwide regulatory strategy across the medical device portfolio, including development, registrations, lifecycle management, and post-market compliance.

This senior role partners with R&D, Quality, Legal, Marketing, and the leadership team to accelerate global market access, build a high-performing regulatory organization, and drive predictable outcomes while managing risk.

Job description

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.

About CooperSurgical: CooperSurgical is a leading fertility and women's healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. As a division of CooperCompanies, we're driven by a unified purpose to enable patients to experience life's beautiful moments. Guided by our shared values - dedicated, innovative, friendly, partners, and do the right thing - our offerings support patients throughout their lifetimes, from contraception to fertility and birth solutions, to women's and family care, and beyond. We currently offer over 600 clinically relevant medical devices to healthcare providers, including testing and treatment options, as well as an innovative suite of assisted reproductive technology and genomic testing solutions. Learn more at www.coopersurgical.com.

Work location: Remote