Regulatory affairs professional with broad experience supporting Class II and III cardiovascular and endovascular devices for US, EU, and international markets. Established track record managing and executing high‐quality regulatory submissions, including PMA Annual Reports, 30‐Day Notices, 510(k)s, design dossier renewals, original technical files, and Canadian license amendments and Special Access applications. 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.