James Mullally

James Mullally is an in vitro diagnostic (IVD) medical device regulatory expert with over 8 years of experience at the FDA, where they directed the review of approximately 1,000 regulatory submissions. Currently, as Vice President of In Vitro Diagnostic Regulatory Affairs at MCRA, they leverage their extensive background to provide innovative solutions to complex regulatory challenges. Previously, James served as Assistant Director at the FDA's Division of Chemistry and Toxicology Devices, where they managed teams responsible for the review of various medical devices and played a leadership role in the COVID Serology Devices Leadership Team. James holds a graduate degree from the University of Utah, where their research contributed to a patented class of enzyme inhibitors and multiple peer-reviewed publications.