Regulatory Affairs and Services (M.S.)

Part-Time

Program
Requirements

Complete admission and program requirements are found in the University Catalog.

Courses

The RAS Part-Time program is a two-year program designed to meet the needs of 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.

Our online Regulatory Affairs and Services 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.

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.