Stephanie Birkholz

Stephanie Birkholz, MSRS, RAC, is an accomplished regulatory affairs specialist currently serving as Principal Regulatory Affairs Specialist at Treace Medical Concepts, Inc. since January 2024, focusing on regulatory management for patient-specific orthopedic devices. Previously, at Boston Scientific from July 2016 to December 2023, Stephanie led strategic regulatory initiatives and played a key role in successful global programs, including the launch of SAP S/4HANA for regulatory product distribution controls. Additional experience includes regulatory roles at Greatbatch Medical, CR Bard, and Medtronic, where Stephanie managed FDA submissions, international regulatory approvals, and project oversight, demonstrating deep expertise in regulatory compliance and process improvement. Stephanie holds a Master of Science in Regulatory Science and has completed graduate certificates in Clinical Studies and Medical Device Development from the University of St. Thomas, alongside a Bachelor's degree in Physics from Hamline University.