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
Advance Your Career with a Master of Science in Regulatory Science
The Master of Science in Regulatory Science at the University of St. Thomas prepares you to thrive in the rapidly evolving field of medical device Regulatory Science. Gain the expertise needed to ensure compliance with regulations and drive innovation in the industry.
Why a St. Thomas M.S. in Regulatory Science?
- In-Demand Expertise: Regulatory professionals are essential in ensuring product safety and efficacy, making this field increasingly critical in today’s health-focused market.
- Industry-Focused, Comprehensive Curriculum: Our program is developed in collaboration with industry leaders, ensuring that the curriculum aligns with current demands and effectively prepares you for the challenges of the regulatory landscape.
- Learn from Industry Leaders: Benefit from a curriculum designed and taught by experienced faculty who have extensive backgrounds in regulatory affairs. Their real-world insights will equip you with practical knowledge that can be applied immediately in your career.
- Networking Opportunities: Join a robust community of professionals, alumni, and industry experts. Networking can lead to mentorship opportunities, job placements, and collaborations that enhance your career prospects.
- Immediate Career Impact: Graduates of our program are well-prepared to enter the workforce or advance in their current roles, equipped with the skills necessary to make immediate contributions to their organizations.
- Flexible Learning Options: Our program offers the flexibility of part-time and full-time study, with evening classes designed to accommodate working professionals, allowing you to balance your education with your career. The M.S. in Regulatory Science is an 11 course (33 credit) program.
- Supportive Learning Environment: Engage in a collaborative atmosphere that encourages professional growth and development.
- STEM-approved: All our graduate programs are STEM-approved.
Contact
Marielle Lejcher
Program Director, M.S. in Regulatory Science
Email
lejc5893@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
The St. Thomas Advantage
Breaking Into Medical Regulatory Affairs
Discover how the University of St. Thomas MS in Regulatory Science program is shaping careers in the medical device industry! Learn how evening classes, industry-veteran instructors, and real-world projects create a powerful learning experience designed for working professionals.
Flexible Graduate Programs To Help You Meet Your Educational Goals
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.
Learn About the Program Benefits for Your Career
"Combination Products, Drugs & Biologics" course in the MS in Regulatory Science Program
Hear from MS in Regulatory Science instructor and Canopy Regulatory Solutions founder, Georgiann Keyport. Georgiann discusses the content, features and benefits of this St. Thomas course.
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
See course descriptions in the Graduate Programs in Engineering (ETLS) course catalog.
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 Tier I Countries
- ETLS 880 Regulatory Science Project
Choose two technical electives (six credits) from the categories below:
Preferred Regulatory Science Electives:- ETLS 601 Program/Project/Team Management
- ETLS 720 Physiology and Medical Devices
- ETLS 734 Clinical Evidence and Reimbursement
- ETLS 738 International Regulatory Affairs for Medical Devices Tier II
Other Popular Regulatory Science Electives:
- ETLS 501 Production Operating Systems
- ETLS 502 Manufacturing Processes
- ETLS 671 Human Aspects of Technical Management
- ETLS 771 Materials Engineering
- ETLS 513 Technical Communications
- ETLS 506 Statistical Methods for Manufacturing Quality
Please note suggested course sequences assume either a fall or spring semester start. Please talk with your advisor if you have questions.
Suggested course sequence with a fall semester start:
- Fall semester 1: ETLS 721/ ETLS 722
- Spring semester 1: ETLS 520/ ETLS 724
- Fall semester 2: ETLS 731/ ETLS 735
- Spring semester 2: ETLS 737/ ETLS 660
- Summer semester: ETLS 734 (Elective)
- Fall semester 3: ETLS 880/ ETLS 738 (Elective)
Suggested course sequence with a spring semester start:
- Spring semester 1: ETLS 520/ ETLS 724
- Fall semester 1: ETLS 721/ ETLS 722
- Spring semester 2: ETLS 737/ ETLS 660
- Summer semester: ETLS 734 (Elective)
- Fall semester 2: ETLS 731/ ETLS 735
- Spring semester 3: ETLS 880/ ETLS 720 (Elective)
Learn from Expert Faculty
Marielle Lejcher
Marielle Lejcher is the current program director of the M.S. in Regulatory Science program at St. Thomas. Ms. Lejcher has experience as an instructor for the University of St. Thomas School of Engineering in the area of regulatory affairs for medical devices. Marielle has significant experience in design and development, quality systems, risk management, biocompatibility, and international and US regulatory affairs. She is an accomplished quality and regulatory leader with more than 20 years of experience in medical devices and in vitro diagnostics, with risk strategy and FDA policy as her key areas of focus.
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.