Stephanie Fitts, PhD is a degreed engineer with 30 years’ experience in the medical device space.  She specializes in Regulatory Affairs, Quality Assurance and Clinical Research for devices of all risk categories and numerous therapeutic areas.  Dr. Fitts is focused on leading the Regulatory strategy for Galaxy’s transition from CLIA laboratory service provider to diagnostic medical device developer. 

Dr. Fitts has a PhD in Bioengineering from Pennsylvania State University. She brings a wealth of experience from leadership roles ranging from multi-billion dollar multinational MedTech companies to small pre-commercial enterprises. Most recently, she served as Vice President of Global Regulatory Affairs and Quality Assurance at Align Technology, her prior leadership roles include surgical robotics (TransEnterix), spinal implants and instruments (TranS1), orthopedic devices (Stryker) and cardiac and neurology devices (Medtronic).