Regulatory Affairs and Services

Other Information

Graduate Catalog: Regulatory Affairs

  • Admission requirements
  • Program details
  • Course descriptions

Application Deadlines

Department: Applied Education in MedTech Industry

Graduate Director:
Dr. Larry Kuusisto
lkuusisto@stcloudstate.edu

Program Overview

The Master of Science in Regulatory Affairs and Services program (RAS) focuses on the specific educational and career development needs of employees responsible for managing the required regulatory approval processes in the medical device industry. The intent of the program is to prepare students to take leadership roles within the regulatory departments of medical device organizations.

The program will meet the educational needs of part-time students via flexible and varied delivery, responsive curriculum, a professionally qualified staff, an industry advisory council, with consistent support. Design of the program is for working professionals in Minnesota and surrounding areas. The degree program draws support and expertise from consulting (working professionals) and SCSU faculty. The major area of study in the program are: 1.) State, National and International Regulatory Affairs, 2.) Clinical Trials and Quality Systems, and 3.) Health Economics/reimbursement. The curriculum is comprised on eight required courses and two elective courses from a series of elective options. The program delivery model will be offered at the SCSU Graduate Center in Maple Grove.

The Profession

The regulatory affairs professional is critical to making safe and effective medical products available to patients worldwide. These professionals ensure compliance to state, federal and international medical device regulations for safety and efficacy. In successful medical device companies, regulatory professionals are involved in all stages of the commercialization process, from initial business planning to design, development, verification, pre-clinical, clinical, manufacturing, packaging, labeling, marketing and post-market surveillance.

The regulatory profession requires versatile individuals with excellent communications skills and a broad knowledge of the following: science and engineering; state, federal and international regulations; and planning and risk management. Increasingly, the success or failure of medical device businesses depends on regulatory affairs, clinical and reimbursement strategies and implementation. As a result, regulatory professionals are taking leadership roles within medical device organizations, and the demand for well-trained and skilled regulatory professionals is growing significantly.

Interested in Courses Only?

Do you have an undergraduate degree and work in the industry? Would you like to access stand alone courses? Most introductory RAS courses are open to interested parties without having to seek admission to the master's program. You can seek approval to register as a special student (student guest) by completing the Special Student Registration form. Complete the online form and submit electronically. Usually, within 24 hours an e-mail will be sent offering permission, if appropriate to register for RAS courses.

Please note: Graduate student guests are not admitted to SCSU, the School of Graduate Studies, nor our programs or departments, and are thus ineligible for any financial aid, graduate assistantships, or scholarships offered by SCSU. Faculty advisers are not assigned to graduate student guests. All guest students who register for graduate credit are subject to the academic regulations and policies contained in the graduate catalog.

The credits earned as a graduate guest are not guaranteed to be used within a degree program should the student decide to seek admission at a later date. It will be at the department's discretion at the time of admission to decide on the use of your graduate guest credits. Generally, a maximum of six semester credits may be applied toward a degree program with the approval of the department and the dean of graduate studies. Student guests cannot complete any graduate degree program through this registration category. 

Admission Information

  • International applicants: This program is now available on a full time basis, allowing you an opportunity to apply and attend.
  • Admission decisions are made throughout the year as completed application files are received. Students may be admitted for fall, spring and summer terms.
  • The director and selected instructors from the Academic Center for Regulatory Affairs and Services will review applications to ensure each candidate’s qualifications.

Length of Program - Measured by Semesters

  • Full-time student:
  • Part-time student: six semesters over two years.

Program Location

The program is offered at the Twin Cities Graduate Center located in Maple Grove, Minnesota. 

  • Computer lab, classrooms, and breakout areas are available for this program.
  • Students will have full access to electronic resources via a SCSU HuskyNet account, and instruction will be provided by course management software, currently D2L.