Vice President, Regulatory Affairs Greater New York City, NY Area

The Company is seeking a Global Head of Regulatory Affairs to lead the establishment and execution of worldwide regulatory strategies for its medical device portfolio. This senior leadership role is pivotal in ensuring regulatory excellence, enabling innovation, and supporting global market access. The successful candidate will be responsible for all regulatory activities, from new product development to post-market compliance, and will serve as a strategic business partner to the executive leadership team. Key responsibilities include developing and executing global regulatory strategies, providing regulatory leadership throughout the product development lifecycle, and overseeing all global regulatory submissions and market access activities. The role also involves engaging with health authorities, leading regulatory due diligence for M&A activities, and fostering a culture of accountability and operational excellence within the regulatory affairs organization. Applicants for the Global Head of Regulatory Affairs position at the company should have a Bachelor's degree in a relevant scientific discipline, with an advanced degree strongly preferred. A minimum of 15-20 years' progressive regulatory affairs experience in the medical device, diagnostics, or broader life sciences industry is required, with at least 10 years in a leadership role. The ideal candidate will have a deep understanding of global regulatory requirements, including FDA regulations, EU MDR, and ISO standards, and a proven track record of successful regulatory strategy execution for complex medical device portfolios. Experience in women's health, fertility, reproductive health, or related markets is preferred. The role demands a leader with exceptional executive presence, strong business acumen, and the ability to influence and drive organizational performance in a dynamic, rapidly evolving environment.

Hiring Company

CooperSurgical