Vice President of Regulatory Affairs

Vice President of Regulatory Affairs

About the Company

A pioneering medical device company developing first-in-class technologies addressing critical unmet clinical needs.

Industry
Medical Devices

Type
Privately Held

About the Role

The Company is in search of a Vice President of Regulatory Affairs to spearhead the global regulatory strategy for a portfolio of Class III device programs, with a primary focus on PMA approvals. The successful candidate will be a key member of the leadership team, responsible for influencing company strategy, clinical development, and commercialization plans. This executive-level role demands a proven regulatory leader with a strong background in PMA submissions, IDEs, and complex FDA interactions for high-risk devices. The VP will also be tasked with overseeing all regulatory activities, providing strategic guidance on clinical and regulatory requirements, and building a high-performing regulatory organization. Applicants for the Vice President of Regulatory Affairs position at the company should hold a Bachelor's degree in engineering, life sciences, or a related discipline, with an advanced degree strongly preferred. A minimum of 15 years' regulatory affairs experience in the medical device industry, including senior leadership roles, is required. The ideal candidate will have a track record of success in leading PMA submissions and securing approvals for Class III devices, as well as deep expertise in FDA engagement and a strong understanding of clinical trial design and regulatory evidence requirements for high-risk devices. Experience across global regulatory frameworks and executive leadership experience in building and mentoring regulatory teams are also essential. The role demands excellent communication skills and the ability to influence at the board and executive level.

Functions

• Operations