Bolette Nordby

Bolette Nordby is a highly experienced professional in the medical devices and quality assurance sector, currently serving as Director of Medical Devices and Quality Assurance at Ascendis Pharma since September 2021. Responsibilities include managing the Quality Assurance Medical Device team, establishing and maintaining compliant quality management systems, supplier management, regulatory submissions, and training related to Drug-Device Combination Products. Prior to this role, Bolette held a similar position at Ferring Pharmaceuticals, leading a multi-site quality management system compliant with ISO 13485 and 21 CFR Part 820. Previous experience includes lead auditor roles, project management in R&D for companies like Coloplast and Maersk Medical A/S, and consulting for the Danish Technological Institute on medical devices. Bolette holds a Master’s degree in Materials Science and Engineering from the Technical University of Denmark.