Michelle Rubin Onur
About Michelle Rubin Onur
Michelle Rubin-Onur is the Director of Regulatory at Enzyme, specializing in regulatory strategies and submissions for a wide range of medical devices.
Michelle Rubin-Onur Director of Regulatory
Michelle Rubin-Onur serves as the Director of Regulatory. In this role, she has demonstrated leadership in developing regulatory strategies and managing premarket submissions for various medical devices. Her expertise spans across Class I-III devices, including radiation therapy systems, implantable markers, surgical instruments, nerve stimulators, in-vitro diagnostics, SaMD, and powered wheelchairs. By ensuring compliance with regulatory standards, she plays a critical role in the development and approval of innovative medical technologies.
Michelle Rubin-Onur Education and Expertise
Michelle Rubin-Onur holds a PhD in Biomedical Sciences from Baylor College of Medicine. Her academic background has equipped her with extensive knowledge and skills in the field of biomedical sciences. Throughout her career, she has applied this expertise to the regulatory landscape of medical devices, contributing to the successful navigation of complex regulatory environments. Her specialized knowledge enables her to lead regulatory strategies effectively for diverse medical device categories.
Michelle Rubin-Onur Background in Regulatory Affairs
With a robust background in regulatory affairs, Michelle Rubin-Onur has authored and led numerous premarket submissions for a wide range of medical devices. Her work includes handling regulatory processes for Class I-III devices such as radiation therapy systems, implantable markers, surgical instruments, nerve stimulators, in-vitro diagnostics, SaMD, and powered wheelchairs. This extensive experience has established her as a key figure in ensuring medical device compliance and market entry.
Michelle Rubin-Onur Role at Enzyme
Michelle Rubin-Onur joined Enzyme in 2023. As the Director of Regulatory, she applies her comprehensive regulatory expertise to contribute to the company's mission. At Enzyme, she focuses on developing and managing regulatory strategies, ensuring that medical devices meet all necessary regulations and standards for market approval. Her role is pivotal in guiding the company through the regulatory landscape, leveraging her experience in handling premarket submissions for a diverse array of medical devices.