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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.

Changing lives with technology

Make a Difference In a Growing Field

Opportunity web from a regulatory science degree

Choose a Career in Regulatory Science

Earn an M.S. in Regulatory Science

  1. Growth: The health technology industry is projected to continue growing over 5% per year in the medical device field.*

  2. 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.

  3. 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

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.

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.

View our Course Schedule

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

Other electives:

  • ETLS 501 Production Operating Systems
  • ETLS 502 Manufacturing Processes
  • ETLS 571 Automation in the US and Overseas
  • ETLS 671 Human Aspects of Technical Management
  • ETLS 771 Materials Engineering
  • BCOM 535 Persuasion
  • BCOM 543 Team Skills and Group Processes
  • BCOM 551 Presentational Speaking
  • BCOM 640 Technical Writing
  • SEIS 605 Technical Communications

ETLS = Graduate Engineering Courses
BCOM = Graduate Business Communications Courses
SEIS = Graduate Software Engineering Courses

Graduate Programs in Software (SEIS) course catalog
Graduate Programs in Engineering (ETLS) course catalog


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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.

Admission Info
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Attend an Information Session

Attend an online information session to get program details and receive $20* off your application fee just for attending. 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.

*St. Thomas alumni, St. Thomas returning graduate students, St. Thomas employees, and all U.S. active and retired military personnel and veterans are eligible for a full $50 application fee waiver.

Join us for an info session

Faculty

Michael Winegar

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.

Michael Winegar
Kristina Simmons.

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.

Kristina Simmons
Georgiann Keyport

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.

Georgiann Keyport