Sean Bundy, RAC
Director of Regulatory and Quality Affairs
As Director of Quality Assurance and Regulatory Affairs at HepQuant, Sean Bundy brings two decades of regulatory, clinical and quality processes for large life sciences organizations. In this role, Mr. Bundy is responsible for proactively developing, leading and driving the execution of a global regulatory and quality strategy with a focus on efficient, rapid and timely approval of the HepQuant liver test product suite. 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.
Most recently, 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.