Michelle Rubin-Onur

Michelle Rubin-Onur serves as the Director of Regulatory at Enzyme, a position she assumed in 2023. She holds a PhD in Biomedical Sciences from Baylor College of Medicine. In her role, Michelle has authored and led numerous premarket submissions and developed regulatory strategies for a diverse array of medical devices. Her expertise spans Class I-III devices, including radiation therapy systems, implantable markers, surgical instruments, nerve stimulators, in-vitro diagnostics, Software as a Medical Device (SaMD), and powered wheelchairs. Her extensive knowledge and experience have been pivotal in navigating complex regulatory pathways and ensuring compliance with medical device regulations.