I hold a Bachelor’s in Project Management and a Master’s in Regulatory Affairs, with 15 years of experience across medical devices, in vitro diagnostics, and pharmaceuticals. I have extensive expertise in regulatory strategy, global submissions, and quality system implementation. Throughout my career, I have successfully authored 510(k) submissions, managed design control processes, and facilitated FDA interactions, including leading meetings and ensuring compliance.
My background includes working with cross-functional teams across R&D, Quality, and Operations, where I contributed to new product development, design validation, and addressing CAPAs. I’ve worked on regulatory requirements for Class II and III devices, PMAs, and international registrations in markets such as Canada, Latin America, and Europe. I’m passionate about using my skills and experience to help bring new and innovative products to market