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    Mac McKeen

    Regulatory Scientist engaged in advancing medical device technology and therapies in both business and academia for the benefit of patients worldwide.

    Mac McKeen is a Regulatory Scientist with over 35 years of experience in the medical device industry, currently serving as a Fellow, Regulatory Science at Boston Scientific.1 He specializes in advancing medical device technology and therapies for the benefit of patients worldwide.1

    Career Highlights

    • Boston Scientific: Fellow, Regulatory Science since June 20111
    • University of Minnesota: Adjunct Professor since January 2009, teaching medical device product development and approval1
    • Previous roles: Leadership positions at Guidant, Medtronic, and St. Jude Medical12

    Expertise

    • Regulatory affairs and quality compliance for Class II and III medical devices1
    • Product development, clinical studies, and regulatory approvals1
    • Ethylene Oxide sterilization processes and global sterilization network operations1

    Education and Certifications

    • BS in Industrial Technology from Iowa State University1
    • MBA in Contract Administration from the University of Dallas1
    • Regulatory Affairs Certification (RAC)1
    • Fellow of the Regulatory Affairs Professionals Society (FRAPS)1

    Awards and Recognition

    • Spirit of the Alley Award from The Medical Alley Association in 20161
    • Peter Nicholas Award from Boston Scientific Corporation in 20161

    Mac McKeen is known for his strategic partnership with businesses, providing regulatory guidance and building products, programs, and processes for growth in regulated markets.1 He is also actively involved in industry associations and committees, advocating for advancements in life science policies and regulatory reform.1

    Highlights

    Regulatory affairs career tips from Boston Scientific's Mac McKeen
    Regulatory affairs career tips from Boston Scientific's Mac McKeen
    AI Strategic Committee - Healthcare Products Collaborative

    Related Questions

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    What specific roles did Mac McKeen hold at Boston Scientific?
    How has Mac McKeen's experience in regulatory affairs influenced his teaching at the University of Minnesota?
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    Mac McKeen
    Mac McKeen, photo 1
    Mac McKeen, photo 2
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    Location

    Greater Minneapolis-St. Paul Area