Eliane Schutte

Biography

Ms. Eliane Schutte, MSc serves as Chief Development Officer at Xeltis AG. Previously, she served as Chief Development Officer at ProFibrix B.V. Ms. Schutte has built up an extensive track record at a number of biotechnology companies. Ms. Schutte is also Senior Partner at Signifix BV, a life sciences QA/RA consulting firm she co-founded that provides strategic advice, consulting, and interim management in regulatory affairs and quality systems. At tissue engineering company IsoTis NV (now part of Integra Life Sciences) she served as Vice President Regulatory Affairs & Quality Affairs with responsibilities for the development of the medical devices and regulatory affairs for all IsoTis medical device products as well as for regenerative medicine products in the area of skin, cartilage and bone. She developed successful strategies to obtain regulatory clearance or approval in such diverse markets as the U.S., Europe, the Middle East and Asia, and frequently interfaced with regulators such as the U.S. Food and Drug Administration, the European Medicines Agency, notified bodies, and national regulatory authorities. Ms. Schutte started her career as a Senior QA officer at Medtronic. She holds degrees in Health Sciences and Business Administration and is RAC certified.

Research Interest

 Medical devices and regulatory affairs