Streamlined Admissions Process
A bachelor's degree from a U.S. regionally accredited institution (or international equivalent) and a minimum GPA of 2.7 is required. The GRE/GMAT is not required.
Changing lives with technology
M.S. in Regulatory Science
The M.S. in Regulatory Science is an 11 course (33 credit) program. Medical Device regulatory professionals make a difference in people's lives. These are the individuals who navigate the government's laws and regulations to bring lifesaving and life-enhancing technology to patients. If you are looking for a satisfying, high-paying, in-demand position in this high-growth field, then Regulatory Science may be a great degree choice for you.
Students in this program will learn how to interpret and apply a very broad array of current regulatory requirements for medical devices and combination products. They also acquire the necessary skills to effectively implement future changes in regulations, guidance documents and standards. Students are encouraged to select courses, projects and presentations throughout their program that will best serve their professional interests.
Classes are taught by knowledgeable and experienced working professionals from the Twin Cities area medical device industry.
Contact
Mike Winegar
Program Director, M.S. in Regulatory Science
Email
wine7598@stthomas.edu
Changing lives with technology
Make a Difference In a Growing Field
Choose a Career in Regulatory Science
Earn an M.S. in Regulatory Science
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Growth: The health technology industry is projected to continue growing over 5% per year in the medical device field.*
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Opportunity: Indeed.com currently lists over 1,100 jobs in Minnesota under the heading Medical Devices - Minnesota. Medtronic, Boston Scientific, and Abbott have a total of over 300 job listings alone.
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Salary: The following are average yearly salaries for the medical device regulatory affairs personnel.**
- Vice President: $292,625
- Director: $213,306
- Manager: $138,172
- Specialist: $108,627
* "2019 Health Technology Driving Forces: Navigating the Talent Crisis," Talencio, 2019.
** "Global Compensation and Scope of Practice Report for the Regulatory Profession," Regulatory Affairs Professional Society, 2020
Student Testimonial
"I wouldn't be where I am today without all the support of St. Thomas, which prepared, supported, and laid the foundation for me, providing steppingstones all along the way," said Quentin George, a student in the University of St. Thomas School of Engineering MS in Regulatory Science program.
Learn More About Quentin George
Quentin George - MS in Regulatory Science student
Graduate Programs That Work For You
Our evening class schedules allow both industry professionals and career changers to achieve their educational goals. And each class meets just once per week.
Admission Requirements
Convenient Schedule
Our programs serve working professionals with busy lives. You choose how quickly you move through the curriculum. And you may start either in the fall or spring terms.
Coursework and Degree Requirements
To complete the M.S.in Regulatory Science, students must successfully complete 11 courses (33 credits) and maintain a minimum GPA of 2.7.
STEM Approved Program
Take the following nine courses (27 credits):
- ETLS 520 Design and Manufacturing in Medical Device Industry
- ETLS 660 Engineering Leadership
- ETLS 721 Medical Device Regulatory Submission
- ETLS 722 FDA Medical Device Quality Systems
- ETLS 724 Medical Device Clinical Studies
- ETLS 731 Combination Products, Drugs and Biologics
- ETLS 735 Preclinical Activities
- ETLS 737 International Regulatory Affairs for Medical Devices
- ETLS 880 Regulatory Science Project
Choose two technical electives (six credits) from categories below:
Recommended electives:- ETLS 601 Program/Project/Team Management
- ETLS 720 Anatomy, Physiology and Medical Devices
- ETLS 734 Clinical Evidence and Reimbursement
- ETLS 738 International Regulatory Affairs for Medical Devices Tier II Countries
Other electives:
- ETLS 501 Production Operating Systems
- ETLS 502 Manufacturing Processes
- ETLS 671 Human Aspects of Technical Management
- ETLS 771 Materials Engineering
Graduate Programs in Engineering (ETLS) course catalog
Making your education affordable
St. Thomas Regulatory Science Dean's Scholarship
The School of Engineering will offer up to five $3,000 scholarships to recognize outstanding graduate students and to help support their financial commitments involved in pursuing the M.S. in Regulatory Science degree.
Attend an Information Session
Attend an online information session to learn program details. Our programs serve working professionals with busy lives. Set your own pace and start fall or spring. Classes are offered in the evenings. We look forward to meeting you.
Note: Regulatory Science M.S. program does not have a summer start option.
Faculty
Michael Winegar
Mr. Winegar is the program director of the M.S. in Regulatory Science program at St. Thomas. Mike’s primary focus is in the areas of medical device regulatory affairs, clinical research, and quality assurance. He has more than thirty years of experience with global medical device and biotechnology companies, with a particular emphasis on neurovascular, cardiovascular, peripheral vascular, and regenerative medicine technologies.
Kristina Simmons
Ms. Simmons is an adjunct faculty at St. Thomas and an Engineering Program Director in the Cardiac Rhythm Disease Management Group at Medtronic. She leads a cross functional team in the product development activities for life saving medical technology. Before joining Medtronic, Ms. Simmons held positions in the areas of Sales, Quality Systems, and Regulatory Affairs at Empi Medical and MinRad/BioVector.
Georgiann Keyport
Ms. Keyport is an adjunct faculty at St. Thomas and a Senior Advisor and founder of Canopy Regulatory Solutions Inc., a medical product consulting firm, where she had over 30 years of experience in the regulated medical device, biologic, and pharmaceutical industries as a scientist and in leadership roles in Regulatory & Clinical Affairs, Quality Systems, and Product Development.