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Michelle Rubin-Onur, PhD

Director of Regulatory

Michelle has prior experience as both an in-house regulatory leader and a regulatory consultant. As the Director of Regulatory and Quality at Blue Note Therapeutics, a digital therapeutics company, Michelle owned, developed, and implemented the regulatory strategies for all of the company’s mobile applications, including multiple artificial intelligence/machine learning (AI/ML) products. 

Prior to Blue Note Therapeutics, Michelle worked as a regulatory consultant, authoring and leading numerous premarket submissions and regulatory strategies for Class I-III devices, including radiation therapy systems, implantable markers, surgical instruments, nerve stimulators, in-vitro diagnostics, and powered wheelchairs. Michelle holds a PhD in Biomedical Sciences from Baylor College of Medicine and is passionate about ensuring that patients have access to the clinically proven treatments they need.

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