Angela has over 20 of regulatory affairs and quality assurance experience with various products in the medical device industry specializing in international regulatory affairs working with universities, start-up and blue chip companies. Her expertise reflects her ability to successfully navigate country specific requirements by providing strategic global regulatory strategies and submissions bringing new and existing products to the marketplace outside the US including EU, Canada, South & Latin America, Middle East, Asia, and Africa, as well as the US. She is experienced in transitional regulatory activities to handle the ever-changing global regulatory environment. Angela has a comprehensive knowledge of the regulations for the preparation and writing required for global medical device submissions including EU Technical Documentation (Technical Files/Design Dossiers), Canadian Licensing and Submissions, TGA Technical Documentation, International Product Dossiers, and JSTED, as well as US premarket submissions. Additionally, her expertise in quality assurance provides quality management system alignment as additional geographic regions are incorporated, specifically in post market activities including complaint management, adverse event reporting and recall management. Angela has held various levels of responsibility in regulatory and quality throughout her career prior to joining ICON in 2018. She is an active member of the Regulatory Affairs Professional Society (RAPS), The Organization for Professionals in Regulatory Affairs (TOPRA), and holds a B.S. in health science from Campbell University.
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