M.S. in Regulatory Science
Medical Device regulatory professionals make a difference in people's lives. These are the men and women who navigate the government's laws and regulations to bring life-saving and life-enhancing technology to patients. Chances are you know someone whose quality of life has been enhanced due to a medical device. If you are looking for a satisfying, high-paying, in-demand position in this high-growth field, then Regulatory Science may be a great 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 will also acquire skills allowing them to 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 evenings and weekends, by knowledgeable and experienced working professionals from the Twin Cities area medical device industry.
The Master of Science degree in Regulatory Science is a 33-credit program. Pre-approved electives are available through the School of Engineering or through the many other University of St. Thomas schools and colleges.
Three great reasons to choose a Regulatory career:
- Growth: The health technology industry is projected to continue growing at 4 - 5% per year in the medical device field.*
- Opportunity: Indeed.com currently lists over 2,400 jobs in Minnesota under the heading Medical Devices - Minnesota. Medtronic, Boston Scientific, and Abbott have a total of over 400 job listings alone.
- Salary: The following are average salaries for the medical device regulatory affairs personnel.**
* "2018 Health Technology Market Projections: Navigating the Talent Crisis," Talencio, 2018."
** "Scope of Practice & Compensation Report for the Regulatory Profession," Regulatory Affairs Professional Society, 2016.
A bachelor's degree from a regionally-accredited educational institution in the U.S. (or international equivalent).
An overall grade-point-average (GPA) of at least 2.7 out of 4.0. (Applicants with a GPA less than 2.7 will be considered for provisional admission with their professional experience factored into the decision.)
To complete the requirements for the Master of Science with a major in Regulatory Science, students must successfully complete 33 graduate semester credits and maintain a GPA of at least 2.7.
Students must complete 27 core credits (11 required courses) from Engineering and an additional 6 elective credits from either the School of Engineering graduate course curriculum, Graduate Business classes listed below or other graduate UST program subject to Faculty Advisor approval.
Courses listed are three credits each unless otherwise noted.
ETLS = Graduate Engineering Courses
BCOM = Graduate Business Communications Courses
SEIS = Graduate Software Engineering Courses
All nine courses are required [27 credits]:
ETLS 520 Design and Manufacturing in Medical Device Industry
ETLS 601 Program/Project/Team Management
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 737 International Regulatory Affairs for Medical Devices
ETLS 880 Directed Study (Independent Research)
Select elective courses [6 credits] from the Regulatory Science curriculum or any other UST graduate course list (provided you have the prerequisites met and your faculty advisor has given approval).
Preferred Regulatory Science electives:
ETLS 720 Anatomy, Physiology and Medical Devices
ETLS 730 Cardiovascular Anatomy, Physiology, and Medical Devices
ETLS 734 Clinical Evidence and Reimbursement
ETLS 735 Preclinical Activities
Other Popular Regulatory Science electives include:
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
While there are no prerequisites for any required core course, it is recommended that students take ETLS 721 early in their Program. Doing so provides helpful background information to better understand lecture topics in other required courses.
As some classes are only offered bi-annually, please meet with your advisor for the Regulatory Science program, Mr. Michael Winegar, early in your program to determine the best class sequence.