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    Randy Vader

    Senior Vice President, Regulatory and Quality Affairs at FUJIFILM Healthcare Americas Corporation

    Randy Vader is a highly experienced business executive with a strong background in Global Regulatory Affairs, Quality Management Systems, Quality Assurance, Clinical Affairs, and Corporate Compliance for Medical Device companies.

    With over 20 years of experience, Randy specializes in U.S. FDA and Global Regulatory Submissions and Approvals, including IDE, 510(k), PMA, CDx, BLA, IND, ANDA, NDA, etc., as well as Global Regulatory Requirements encompassing various standards such as ISO and FDA regulations.

    His areas of expertise range from Quality Management Systems, Corporate Compliance, Good Clinical Practice, to Product Categories like Oncology, Cardiology, and Medical Diagnostics.

    Randy Vader has held significant positions in reputable organizations such as FUJIFILM Healthcare Americas Corporation, FDA Compliance Group, Caris Life Sciences, Orthofix, and PHILIPS Healthcare, where he has played crucial roles in leading Regulatory, Quality, Clinical, and Compliance functions.

    He excels in building world-class teams and aligning Regulatory Affairs, Quality Assurance, Clinical Affairs, and Corporate Compliance with business growth and profitability.

    Randy Vader earned his Bachelor of Science degree from San Diego State University and can be reached at (608) 692-7839 or via email at randyvader@sbcglobal.net.

    Randy Vader
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    Location

    United States