Vice President of Regulatory Affairs

Vice President of Regulatory Affairs

About the Company

A pioneering medical device company developing first-in-class technologies for 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 defining and executing regulatory strategy, influencing company vision, and driving the approval process for innovative technologies with a significant impact on patient care. This executive-level role demands a proven regulatory leader with a strong background in PMA submissions, IDEs, and complex FDA interactions, particularly 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 and leading 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 global regulatory frameworks. Executive leadership experience, excellent communication skills, and the ability to influence at the board and executive level are also essential. The role involves close collaboration with cross-functional teams and the development of mitigation strategies to ensure successful product approvals and timelines.

Functions

• Operations