Caroline Byrd

Director, Regulatory Affairs, Abbott

Caroline Byrd

Director, Regulatory Affairs, Abbott

Biography

Caroline (Leab) Byrd is a Director of Regulatory at Abbott and is based in Minnesota. Caroline has led Abbott’s EU Medical Device Regulation implementation program for the Medical Device Division for the last two years, and works closely with Abbott’s Corporate and IVDR program teams. Prior to her full time role as EU MDR Program Director, she managed the Clinical Evaluation process for legacy St. Jude Medical products.

Over her 18 year career in the medical device industry, Caroline has held roles as Director R&D Engineering & Scientific Services for St. Jude Medical, Director of Quality and Operations at Monteris Medical Corporation, Production Quality Manager at AGA Medical, and various Quality and Manufacturing Engineering roles at Nestle Healthcare Nutrition and Boston Scientific.

Caroline is also an industry advocate for Product Lifecycle management approaches that enable data management tools and business processes to efficiently comply to worldwide regulatory and quality requirements. She also serves on the board of directors for The Bakken Museum and various AdvaMed committees. Caroline holds a B.S. in Mechanical Engineering from Washington University in St. Louis.