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 the Twin Cities Graduate Center in Maple Grove. 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 a synchronous Adobe Connect Internet connection.

  • 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 three year of successful experience with remote learning via Adobe Connect.

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.