Vice President of Regulatory Affairs

Vice President of Regulatory Affairs

About the Company

Pioneering medical device company developing first-in-class technologies for high-acuity therapeutic areas.

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 defining and executing regulatory vision, and will have a significant influence on clinical and development strategy. 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, including leading FDA interactions, and will be expected to provide strategic guidance on clinical and regulatory requirements. 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 deep expertise in FDA engagement, a strong understanding of clinical trial design, and experience across global regulatory frameworks. Executive leadership experience, excellent communication skills, and the ability to build and mentor high-performing regulatory teams are also key qualifications for this role. The VP will be expected to partner closely with cross-functional teams to ensure that the regulatory strategy aligns with the company's broader business objectives.

Travel Percent
Less than 10%

Functions

• Operations