Fractyl
Jon Fitzgerald is Vice President of Quality Assurance and Regulatory Affairs at Fractyl. Jon brings more than 20 years of medical device start-up experience to Fractyl.
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 US Navy, Jon studied mechanical engineering at Northeastern University.
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Fractyl
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Fractyl aims to bring curative therapies to the large populations of patients with metabolic disease. With their innovative products, their goal is to truly shift the treatment paradigm for patients with metabolic disease by focusing on their root cause in the intestine to provide meaningful, transformative, benefits to restore patient health from metabolic diseases.