Jon Fitzgerald is Vice President of Quality Assurance and Regulatory Affairs of Fractyl Health.
Jon brings more than 20 years of medical device start-up experience to Fractyl Health.
He has developed and scaled multiple quality systems and has a successful track record of regulatory agency engagement. In addition to his experience in quality, he has successfully conducted recalls, led vigilance activities, and played a pivotal role in global regulatory filings resulting in device clearances and approvals, including the U.S., E.U., Middle East, and Japan.
Previously, Jon held quality engineering and management positions at Neuronetics, Animas (a Johnson & Johnson Company), and Kensey Nash (now DSM Biomedical). His expertise encompasses microbiology, quality management, electronic system implementation, as well as technical file and design dossier development. After serving as an air traffic controller in the U.S. Navy, Jon studied mechanical engineering at Northeastern University.