Sean Bundy, RAC
Chief Operating Officer / Director of Regulatory and Quality Affairs
Sean Bundy was promoted Chief Operating Officer at HepQuant in June 2020. He has served as HepQuant’s Director of Quality Assurance and Regulatory Affairs since July 2018. Mr. Bundy will maintain his focus on the execution of the pivotal SHUNT-V study, as well as ensuring that operational processes related to manufacturing, supply chain, distribution, and laboratory throughput, are ready for commercial-scale volumes. He will continue to act as head of Regulatory and Quality until a replacement is found.
Mr. Bundy has more than two decades of regulatory, clinical and quality processes for large-life sciences organizations. Over the course of his career with Precision Biopsy and Cochlear Americas, Mr. Bundy has an accomplished track record of working closely with the FDA and other regulatory bodies to achieve successes for a number of medical devices.
Prior to joing HepQuant, Mr. Bundy served as Vice President Regulatory and Quality at Precision Biopsy, where he defined regulatory and quality strategy for an early-stage prostate cancer diagnostic tool. In this role he successfully negotiated a De Novo submission approach for an assumed Class III device. Prior to Precision Biopsy, he held a variety of quality and regulatory affairs roles over 12 years at Cochlear Americas. As Director of Regulatory and Quality, at Cochlear Americas, he managed the approval of over 100 PMA supplements, 510(k) clearances and IDE submissions. In his most recent position as Director of Regulatory Strategy at Cochlear Americas, he drove global strategy for marketing authorizations for Class II and Class III medical devices. He led the submission of a Novel PMA for a first-of-kind device, including FDA Panel review.
Mr. Bundy earned a postgraduate diploma in Medical Technology Regulatory Affairs from Cranfield University in Cranfield, England and a postgraduate certificate in Clinical Trials Management from the University of Chicago.