What will I learn?

The University of Washington's Master of Science in Biomedical Regulatory Affairs trains professionals to manage the process of bringing new medical products to market. In this two-year, part-time or full-time program, you'll develop expertise in the regulations governing medical product development and learn how to lead every step of the regulatory process.

Diverse Career Opportunities

Career opportunities in the biomedical regulatory affairs field range from entry level to upper management and from highly technical to business oriented. Regulatory affairs professionals are involved in all aspects of the product life cycle, including areas such as:

  • ensuring compliance with FDA or international regulations
  • planning and supervising clinical trials
  • specifying product labeling and packaging requirements


Students in both the part-time and full-time options complete a practicum. In this course, you’ll get valuable hands-on experience shepherding a new medical product through aspects of the regulatory affairs process at a Seattle-area company or institution. Most students identify their practicum site through individual interests and networking, though placement assistance is available.

You’ll spend at least two quarters on the practicum, working on your project under the guidance of an on-site preceptor and the practicum director.

At the end of their practicum, you’ll produce a final report and presentation for instructors and the rest of your cohort.

Which department am I in?

University of Washington

Study options

Full Time (2 years)

Tuition fees
US$23,010.00 per year
USD $46,020 for the entire course
Start date

Expected September 2022


University of Washington

Schmitz Hall, 1410 NE Campus Parkway,



98195, United States

Entry requirements

For students from United States

Prospective graduate students must meet the following minimum requirements: Hold a baccalaureate degree from a regionally accredited college or university in the U.S.1or its equivalent from a foreign institution; Have earned at least a 3.0 grade-point-average (on a 4 point scale) for the last 90 graded quarter credits or 60 graded semester credits. Other English Language Requirements: 580 paper-based TOEFL.

For international students

Bachelor's degree in a science discipline, health sciences, engineering or law from a regionally accredited college or university in the United States, or its equivalent from a foreign institution

A minimum 3.0 grade point average (on a 4.0 scale) for the last graded 60 semester credits or 90 graded quarter credits

Demonstrated English language proficiency for applicants whose native language is not English

English Proficiency:

The Graduate School is temporarily accepting official test scores for both the Duolingo English Test and the TOEFL ITP Plus For China to assist international students with remote testing options. This policy is currently in effect through the autumn 2021 admission cycle (i.e., students enrolling in autumn 2021).

TOEFL iBT - Minimum Required Score (ELP Required): 80; Recommended Score (ELP Satisfied): 92 or higher

TOEFL pBT - Minimum Required Score: 500

Duolingo: Minimum Required Score (ELP Required): 105; Recommended Score (ELP Satisfied): 120 or higher

IELTS: Minimum Required Score 6.5

*There may be different IELTS requirements depending on your chosen course.


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