Regulatory Affairs and Services (M.S.)
Part-Time
PROGRAM REQUIREMENTS
Complete admission and program requirements are found in the University Catalog.
Courses
The Part-Time program is a two-year program for working professionals.
The program offers two courses in the fall and spring semesters and one course in the summer semester. Courses are offered 9 a.m.-1 p.m. Saturdays and 5-9 p.m. weeknights at St Cloud State at Plymouth in Plymouth. The program is available to students nationally and synchronously online.
Designed by world-renowned expert in regulatory affairs and former head of regulatory affairs at Medtronic Chuck Swanson, the program is taught by industry experts with 10-20+ years of experience in regulatory affairs and related fields.
Online program
The RAS Part-Time program is available to students nationally via Zoom.
- Students connect synchronously to class and actively participate in lectures and discussions.
- All class sessions are recorded for those who might miss a lecture and for study purposes.
- The RAS program has six years of successful experience with remote learning.
AMDM Scholarship
The Association of Medical Diagnostics Manufacturers (AMDM) offers two $5,000 scholarships to Regulatory Affairs and Services graduate students.
Program Track
Year 1
Fall Semester
- RAS-621 Legal Basis for Medical Product Regulation, 3 cr.
- RAS-633 Quality Systems for Regulated Industry, 3 cr.
Spring Semester
- RAS-623 Regulatory Routes to Market: 510(k)s, 3 cr.
- RAS-631 IDE Regulations and Clinical Trial Design, 4 cr.
Summer Semester
- RAS-627 International Regulatory Affairs: European Union, Eastern Europe, Canada and Australia, 3 cr.
Year 2
Fall Semester
- RAS-625 Regulatory Routes to Market: PMAs, 3 cr.
- Elective, 3 cr.1
Spring Semester
- RAS-635 Regulatory Affairs Compliance, 3 cr.
- Elective, 3 cr,
- RAS-690 Regulatory Affairs Culminating Project, 1 cr.2
Summer Semester
- RAS-643 Reimbursement and Cost Management for Medical Technology, 3 cr.
- RAS-690 Regulatory Affairs Culminating Project, 1 cr.
Note: All graduate students must be registered for at least 1 credit in the term in which they intend to graduate.
1Electives selected from RAS, ACR and MTQ courses with advisor approval.
2Timing for registration for RAS-690 may vary depending on the timing of the culminating project.
