Carrie Hetrick, Director of Regulatory Affairs
Carrie has been involved with companies that make medical devices for over 20 years, focusing on the intersection of technology, regulation, and health care and having led numerous quality management and business process improvement/management measures. She has led consultancy regulatory, clinical, and quality business, focusing on helping emerging companies navigate challenges in product development while establishing appropriate clinical, regulatory, and compliance structures. Her expertise in regulatory and clinical affairs led to several successful regulatory submissions and clinical trials in the US and Europe. She is a seasoned subject matter expert in taking new products from R&D to the medical market. Her extensive international experience has helped companies navigate the regulations, providing expertise piloting regulatory, clinical, and operational challenges facing each stage of development. She has proficiency in leading early and late-stage cross-functional medical product development programs, directing activities and teams for all phases of design controls, and creating collaborative and productive alliances with partners.