Jeff Ballyns, PhD
Associate Director, Regulatory Policy, Public Affairs
Jeff Ballyns, PhD is an associate director of regulatory policy at Becton Dickinson and Company (BD). BD designs, manufactures, and sells a wide range of medical devices, including in vitro diagnostic (IVD) products worldwide. He is responsible for gathering, assessing, and communicating new regulatory policy requirements impacting BD businesses. Prior to working at BD, Dr. Ballyns worked in the Center for Devices and Radiologic Health (CDRH) at the US Food and Drug Administration for 8 years. While at the FDA, he served as a lead reviewer, branch chief and division director in the Division of Radiological Health within the Office of In Vitro Diagnostics and Radiological Health. He was responsible for the pre-market review and post-market regulation of radiological imaging devices and artificial intelligence (AI) image analysis software applications. Dr. Ballyns received his bachelor’s and PhD degrees from Cornell University in Mechanical and Aerospace Engineering and Biomedical Engineering respectively.
The Impact of AI and New Technology on Regulatory Compliance