Douglas McGarvey is a seasoned regulatory affairs professional with extensive experience in the medical device industry, currently serving as a Senior Regulatory Specialist at Gold Standard Diagnostics USA since January 2022. Previously, as Regulatory Affairs Manager at Biomed Diagnostics, Inc., Douglas managed all regulatory operations for numerous human and animal IVD medical devices, achieving significant FDA clearances, CE-IVD markings, and Health Canada authorizations. Douglas's background includes roles at QIAGEN, where responsibilities encompassed technical writing and project management for regulatory submissions, and research at Washington State University, contributing to publications in biochemistry. Douglas holds a Ph.D. in Biochemistry - Molecular Biology from UC Santa Barbara and has built a comprehensive skill set that includes regulatory intelligence, process development, and interdepartmental collaboration.
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