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Michele MacHacek

Senior Principal Regulatory Affairs Specialist at Mozarc Medical

Michele Machacek is a Senior Principal Regulatory Affairs Specialist at Mozarc Medical, with a career in regulatory affairs spanning over two decades. Previously, Michele held the position of Principal Regulatory Affairs Specialist at Medtronic, where responsibilities included FDA submissions for Class II and III cardiovascular devices and combination products, along with international submissions across multiple countries. Prior experience also includes serving as a Regulatory Coordinator at Mayo Clinic. Michele holds a Master's degree in Regulatory Science from the University of St. Thomas and a Bachelor of Science in Marketing from Winona State University.

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Mozarc Medical

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Mozarc Medical leverages both companies’ leadership and expertise to develop transformative kidney health technologies. The company focuses on the development of innovative technologies that reshape kidney health with patient-centered solutions.