Extensive experience in bringing medical devices, pharmaceuticals, and combination products to market

Experience in Quality Assurance and Regulatory Affairs managing the product development lifecycle from concept through commercialization of medical devices, pharmaceuticals, and combination products. Thorough understanding of the regulatory requirements and expectations of worldwide regulatory health authorities gained through successful regulatory submissions. Successfully developed and executed quality and regulatory plans guiding teams and projects to meeting milestones. Have had the opportunity to work in R&D, Manufacturing, Clinical, Quality, and Regulatory roles in medical device and pharmaceutical companies acquiring a breadth of experience to help organizations navigate the challenges toward bringing products to market.