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Margaret Curnutte, PhD
Margaret Curnutte is a Senior Director of Regulatory Affairs within Precision for Medicine’s Translational and Regulatory Sciences Practice, with over ten years of experience across research, regulatory policy, and U.S. and major-market regulatory affairs focused on in vitro diagnostics. She has held regulatory roles in both device and pharmaceutical organizations and has led seven U.S. and ex-U.S. companion diagnostic registrations. Her expertise spans CDx development and clinical trial integration, IVD and next-generation sequencing product development, translation of U.S. regulatory strategy to global markets, and leadership of regulatory submissions including Pre-Submissions, IDEs, SRDs, and PMAs.
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