University of Washington

Overview

Biomedical Regulatory Affairs is a graduate program that equips students with a comprehensive understanding of the regulatory processes governing medical products. This course focuses on managing the regulatory pathway from product development through to approval and post-market compliance, ensuring that graduates are well-prepared for careers in this essential field.

Students will develop practical skills in regulatory strategy, clinical trial oversight, technical documentation, and quality and compliance processes related to drugs, biologics, and medical devices.

What you'll study

The curriculum is designed to provide a solid foundation in regulatory knowledge, covering aspects of product development, clinical trials, documentation, and compliance. Students will also engage in applied learning through a practicum experience.

• Biomedical Regulatory Affairs
• Clinical Trials
• Skills for the Regulatory Affairs Professional
• Product Development & Manufacturing Systems
• Implementation & Conduct of Clinical Trials
• Technical Writing for Biomedical Regulatory Affairs

As part of the program, students will complete a practicum at a Seattle-area company or institution, allowing them to apply regulatory concepts in a real-world professional environment.

Entry requirements

Applicants must possess a minimum of a four-year baccalaureate degree from a regionally accredited college or university in the U.S., or its equivalent from a recognized foreign institution. A Bologna bachelor’s degree with at least 180 ECTS credits is also acceptable.

Additionally, applicants must have achieved a minimum cumulative GPA of 3.0 on a 4.0 scale (or equivalent) from a recognized institution.

Career prospects

Graduates of the Biomedical Regulatory Affairs program are well-positioned for successful careers in various sectors, including pharmaceuticals, biotechnology, and medical device industries. The knowledge and skills gained through this program prepare students for roles in regulatory compliance, clinical research, quality assurance, and product management, among others. As the demand for skilled professionals in the regulatory field continues to grow, graduates can expect to find a range of opportunities in both established companies and emerging startups.