About this Program

Regulatory affairs specialists play a vital role in the health care landscape, bridging the legal, business and scientific aspects of developing new biomedical products. This innovative field offers growing career opportunities and the chance to help improve people’s lives. 

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. 

Designed For

Professionals who want to enter or advance in the biomedical regulatory affairs field, or those who want to better understand the subject.

Choose From Credit and Noncredit Options

By completing this certificate program, you can earn up to nine credits toward degree requirements should you later be accepted into the Master of Science in Biomedical Regulatory Affairs. To use these credits, you must enroll in the credit version of the certificate program and obtain graduate nonmatriculated status before you register for the first course. The certificate also has a noncredit option if you don’t plan to pursue a graduate degree.

Learn More

This program is offered by the UW School of Pharmacy and the UW School of Law. For more information and to apply, visit the Certificate in Biomedical Regulatory Affairs on the Master of Science in Biomedical Regulatory Affairs website.