Katherine Gregory

Director Of Regulatory Affairs at 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.

Location

Ithaca, United States

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Transonic Systems Inc.

Transonic –the measure of better results. For clinicians, researchers and specialty solution developers seeking quantitative data to improve their outcomes and results, Transonic provides those measurement solutions. For four decades, the unprecedented resolutions of Transonic measurements has made the Transonic name synonymous with gold standard diagnostic and research measurement tools. Innovative Product Stream Transonic Systems Inc.® was founded in 1983 by R & D scientist/engineer Cornelis J. Drost after he had invented the transit-time ultrasound flowmeter at the NYS College of Veterinary Medicine at Cornell University. As the company grew, continuing measurement innovations were the norm. Transonic measurement tools include intraoperative flowprobes for surgeons, monitors and sensors tailored for hemodialysis and critical care, and specialty sensors customized for original equipment manufacturers.


Employees

51-200

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