Senior Director of Quality & Regulatory Affairs (MedTech)

A medical device startup is seeking a highly experienced Senior Director of Quality Assurance & Regulatory Affairs. This role involves establishing and managing an electronic Quality Management System, ensuring compliance with medical device regulations, and preparing for audits. Candidates should have over 10 years of quality and regulatory experience in medical devices, with a strong emphasis on Class II devices. The position requires leadership in FDA submissions and the ability to navigate a fast-paced environment. #J-18808-Ljbffr