Michelle Ragozzino
Director, Regulatory Affairs @NeuroPace
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WORK HISTORY
Director, Regulatory Affairs @NeuroPace
Mountain View, CA, US
EDUCATION
Massachusetts Institute of Technology
Doctor of Philosophy (Ph.D.), Molecular and Cell Biology
UC Irvine
Bachelor’s Degree, Biological Sciences
SKILLS
ABOUT MICHELLE RAGOZZINO
Regulatory affairs professional with broad experience supporting Class II and cardiovascular and endovascular devices for US, EU, and international markets, and Class active implantable neuromodulation device for US market. Established track record managing and executing high‐quality regulatory submissions, including including Real-Time PMA Supplements, 30‐Day Notices, PMA Annual Reports, 510(k)s, design dossier renewals, original technical files, and Canadian license amendments and Special Access applications. Extensive experience reviewing advertising and promotional materials.Creative and results‐oriented leader successful in driving complex projects to on‐time completion. Regulatory core team member on new product development teams, providing regulatory strategy and tactical support throughout the development process. Strong analytical skills and capable of reviewing and interpreting technical data from many sources. Adept reviewer of change management documentation and advertising and promotional materials. Articulate presenter and good writer, with excellent attention to detail.
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