Sr. Director, Regulatory Affairs
Optum
Tracey Fox, MS RAC, Sr. Director Regulatory Affairs at Optum, has an extensive background in quality and regulatory affairs having previously worked at GE Healthcare and IBM Watson Health in global regulatory affairs. She has worked across a variety of medical devices including AI/ML, Software, Imaging Devices and supported the products throughout the lifecycle including service and refurbishment. She has led a global team and supported registrations in all major regulated markets. Tracey has also been involved in numerous acquisitions and integrations. Qualifications include Six Sigma Master Blackbelt, Lead Quality System Auditor, Certified Quality Engineer, and US Regulatory Affairs Certification (RAC). Her educational background includes a bachelor's degree in Industrial Engineering from Marquette University, and a master's in Regulatory Affairs from San Diego State University.
Disclosure information not submitted.
Tuesday, September 13, 2022
3:30 PM – 4:30 PM MST