Enzyme is excited to announce that Michelle Rubin-Onur, PhD has joined the company as Director of Regulatory. In her new role, Michelle will review submissions for Enzyme clients and consult with them on regulatory strategy. In addition, she will provide valuable input on Enzyme’s product roadmap to ensure the company continues to provide the only QMS as innovative as its clients.
“I am very excited to join Enzyme,” said Michelle. “It is a unique company that not only provides a software solution but also personalized consulting services. I strongly believe that regulatory agencies, such as the FDA, are partners in the total product lifecycle, and I look forward to supporting our clients through all aspects of their regulatory needs.”
“Finding the right regulatory talent for a company like Enzyme is no small feat,” said Jared Seehafer, CEO & co-founder of Enzyme. “You need someone with enough experience to be able to skillfully represent your clients to FDA and other regulatory agencies, while at the same time having the ‘roll with the punches’ attitude necessary to be successful in a startup environment. Michelle has all that and more, and we’re delighted to have her onboard.”
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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