Transonic Systems Inc.
Katherine Gregory is a seasoned professional in regulatory affairs, currently serving as the Director of Regulatory Affairs at Transonic Systems Inc. since June 2021, following previous roles as a Regulatory Manager and Regulatory Validation Engineer. Responsibilities include updating engineering processes to comply with ISO & IEC standards and MDR, developing processes for Software Development, Cybersecurity, and Human Factors Engineering, and managing CAPAs across departments. Katherine has MDSAP audit experience, is trained in internal auditing (ISO 13485:2016), and has served as a Risk Management Owner for multiple clinical products. Prior to Transonic Systems, experience includes a work study position at Union College and participation in clinical immersion at Albany Med. Katherine holds a Master's degree in Biomedical Engineering from the University of Rochester and a Bachelor's degree in Bioengineering and Biomedical Engineering from Union College.