Regulatory Affairs and Services (M.S.)

Full-Time

Program
Requirements

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

Courses

The RAS Full-Time program is a two-year, 36-credit program with an industry internship.

Students take a minimum of 8 credits per semester in the fall and spring. This meets the full-time enrollment requirement for international students.  

It is designed to meet the needs of international students and others who can register for a full time program and participate in an industry internship. The program is located in the Twin Cities, a leading economic area with high employment specialization and share of the medical device industry.

The industry internship requires 2 credits in the fall and spring semesters of the second year. Students will spend about 20 hours per week working on a variety of regulatory activities in the medical device industry.

The internship combines the application of knowledge students have gained from coursework with mentoring by company regulatory professionals.

Our online Regulatory Affairs and Services program

The RAS Full-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 more than five years of successful experience with remote learning via Adobe Connect.

Learn more about becoming an international student

Find out what you need to know as an international student studying at St. Cloud State University by visiting our Center for International Studies

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.
  • ACR-622 Life Cycle of the Clinical Product, 2 cr.

Spring Semester

  • RAS-623 Regulatory Routes to Market: 510(k)s, 3 cr.
  • RAS-631 IDE Regulations and Clinical Trial Design, 4 cr.
  • Elective, 1 – 3 cr.1

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.
  • RAS-644 Regulatory Affairs Internship, 2 cr.

Spring Semester

  • RAS-635 Regulatory Affairs Compliance, 3 cr.
  • Elective, 3 cr.
  • RAS-644 Regulatory Affairs Internship, 2 cr.

Summer Semester

  • RAS-644 Regulatory Affairs Internship, 1 cr.2

1Year 1 spring semester elective requires a minimum of 1 credit.  With advisor approval, options include 1 – 2 credits of independent study or a 3 credit RAS, ACR or MTQ course.
2The summer internship credit is required only if a 1 credit elective is chosen for the year 1 spring semester elective.