Vice President of Regulatory and Clinical Affairs

Vice President of Regulatory and Clinical Affairs

About the Company

Pioneering organization in the oncology industry

Industry
Hospital & Health Care

Type
Privately Held

About the Role

The Company is in search of a Vice President of Regulatory and Clinical Affairs to play a pivotal role in the development and approval of innovative medical devices, with a focus on oncology. The successful candidate will be responsible for leading the product development and regulatory approval efforts, including the creation and submission of various regulatory documents to authorities such as the FDA and Health Canada. This role demands a professional with a strong background in scientific, technical, regulatory, and business issues, who can apply this knowledge to the product strategy throughout its lifecycle. Experience in the oncology space, particularly with brain tumors, is highly valued, and a background in early-stage start-ups is a significant advantage. Applicants for the Vice President of Regulatory and Clinical Affairs position at the company should hold a BA/BS degree and have a minimum of 10 years' experience in clinical and regulatory affairs within the medical device industry. A background in oncology, especially with a focus on brain tumors, is a major plus. The role requires a candidate with a proven track record in developing approval strategies and a deep understanding of the regulatory processes involved. The ideal candidate will have a strong foundation in the scientific, technical, and business aspects of product development and commercialization, and be adept at navigating the complexities of regulatory review. Early-stage start-up experience is highly desired, as the company is looking for a professional who can thrive in a dynamic and innovative environment.

Hiring Manager Title
Chief Executive Officer (CEO)

Travel Percent
Less than 10%

Functions

• Medical Care/Hospital Administration