Kristin Benokraitis

With a passion for innovation and a proven track record of over 20 years in the biotech industry, Kristin Benokraitis is a seasoned leader focused on the development of combination products and medical devices. Her background of roles in regulatory, quality, product development and program management have given her a unique end-to-end perspective. She is an entrepreneurial spirit, who enjoys building, strategy and solving difficult problems. In her current role as Biogen’s Global Head of Regulatory CMC Device and Combination Products, Kristin has strategic oversight of a diverse portfolio of combination products, medical devices and diagnostic products. In her role, she provides strategic regulatory guidance for late-stage development programs, as well as lifecycle management of globally marketed products. Previous to her role at Biogen, she spent 15 years at Gilero, a contract design and manufacturer for the life sciences industry. As a member of Gilero’s executive leadership team, Kristin was responsible for the global expansion of contract design and manufacturing operations. During her time there, she implemented the company’s quality management system, authored multiple regulatory submissions and led 15+ successful product commercial launches. Prior to her time at Gilero, she held roles in quality at Boston Scientific and process engineering at Honeywell. Kristin received her B.S. in Chemical Engineering from Virginia Tech. She holds 5 issued patents in the field of medical devices and is Six Sigma certified.