Kaitlin M. Carroll, MPH, PhD, is a senior clinical and regulatory leader with 15+ years spanning academic medicine and industry, with training and early research experience at Massachusetts General Hospital and deep roots in Hospital for Special Surgery (HSS) / Weill Cornell–affiliated orthopedics and device innovation programs. She has led high-stakes regulatory pathways, including three FDA De Novo classifications and multiple FDA 510(k) clearances, and has executed clinical programs across medical affairs, clinical operations, and pharmacovigilance. Her track record includes building and running clinical teams, activating multi-site trials and agreements, and delivering the evidence packages that move new technologies from development to real-world adoption. Her work has also contributed to peer-reviewed research and national discussions on outcomes, safety, and policy in orthopedic care.