CBSET Appoints Michael C. John as Chief Regulatory Officer

CBSET, a prominent provider of translational research and product development services for the medical device, pharmaceutical, diagnostic, and biomedical research industries, has announced the appointment of Michael C. John as Chief Regulatory and Innovation Officer. In this expanded role, Michael will lead the creation of a new Regulatory Consulting Business Unit, offering professional consulting and FDA advisory services for IND, PMA, 510(k), and other regulatory submissions. He will also drive the growth of CBSET’s service offerings through strategic acquisitions and partnerships, enabling the company to deliver more comprehensive solutions across the entire product development lifecycle.

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Michael brings over 30 years of experience in medical device research and development, regulatory strategy, and product innovation. His career includes leadership positions at MedTech and regulatory consulting firms, as well as more than a decade at the FDA, where he served as Chief of the Interventional Cardiology Devices Branch. At the FDA, he oversaw multidisciplinary teams of scientists, engineers, biologists, statisticians, and medical officers, and held signatory authority for a wide range of 510(k) and Class III (PMA) medical devices.

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Peter M. Markham, President and CEO of CBSET, said that Michael’s expertise in advanced medical technologies and regulatory affairs will allow the company to launch a premier regulatory services offering and provide clients with guidance through every stage of product development. CBSET Co-founder and Board Chairman Elazer Edelman added that Michael’s vision, leadership experience, and track record of achievement will help drive the company’s continued growth in supporting advanced medical therapies.

Michael C. John expressed that he is honored to join CBSET during a transformative period. He emphasized that the company’s distinguished reputation in scientific rigor, technical expertise, and regulatory leadership positions it uniquely to provide clients with a full range of clinical, scientific, and regulatory support. He looks forward to expanding CBSET’s presence in the healthcare ecosystem by broadening service offerings and pursuing strategic acquisitions and partnerships.

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