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    Jeffrey Wallace

    Sr. Program Director at Beaver-Visitec International, Inc

    Jeffrey Wallace is a forward-thinking management professional with over 25 years of experience in the medical device industry. He has a proven track record of directing product development teams and excelling in key roles at major industry corporations. Jeffrey is skilled in driving compliance with US and international regulations for hardware, software, and intelligent device systems.

    Jeffrey Wallace is a diligent strategist known for producing high-impact medical devices that incorporate the latest technologies while being cost-efficient. He excels in establishing collaborative partnerships across internal departments and managing external stakeholders. Jeffrey is adept at streamlining product development lifecycles, reducing costs, and ensuring regulatory compliance.

    His areas of expertise include executive and departmental leadership, FDA inspection and preparation, project management, quality assurance, regulatory compliance, and FDA QSR and GMP. Jeffrey is well-versed in ISO standards, including 62304, 14971, 13485, and 9001, as well as UL/IEC regulations and certifications such as 60601-1. He has experience with 510 k and PMA submissions, Meddev, CE certifications, EU MDR remediation, and verification and validation of medical devices.

    Jeffrey studied BA in Electronic Engineering Technology at ITT Technical Institute. Throughout his career, he has held various positions such as Sr. Program Director at Beaver-Visitec International, Inc, Project Engineer at BD, Project Manager at Risk Based Engineering, LLC, and Regulatory and Compliance Consultant at Oxford Global Resources. He has also served as SVP Product Development and Compliance at Breakthrough Medical Innovations, Sr. Vice President of Product Development and Innovation at MELA Sciences Inc., Partner and Senior Consultant at SoftwareCPR, President and Consultant at ValidationCPR, Quality Assurance Test Engineer at Baxter Healthcare, and Aviation Electricians Mate in the United States Navy.

    Highlights

    Nov 27 · bvimedical.com
    Management team - BVI Medical
    May 7 · theorg.com
    Leadership Team - BVI Medical - The Org

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    Location

    Southbury, Connecticut, United States