James Wu

Regulatory and Quality at SOLIUS

James has extensive experience in the medical device industry working with Class II and Class III devices. Throughout his career, James has interacted with the U.S. FDA and Health Canada. As the lead for quality and regulatory activities at SOLIUS, James ensures end-to-end quality and compliance from development through manufacturing, distribution, and the end-customer experience. Prior to joining SOLIUS, James was employed as a product development engineer at Zimmer Biomet and St. Jude Medical. James holds a Bachelor of Science degree in Biomedical Engineering with a minor in Electrical Engineering.

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  • Regulatory and Quality

    Current role

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