In this three-course certificate program, you’ll learn about the roles and responsibilities of regulatory affairs professionals in the development of new medical products. We’ll explore the regulatory jurisdiction of the U.S. Food and Drug Administration. You’ll delve into the laws and regulations that apply to the design, development, testing and production of biomedical products, including biologics, drugs, biotechnology-derived therapeutics, vaccines and medical devices, including software as a medical device. We’ll also examine post-market issues and requirements.