Regulatory Affairs and Services Graduate Program (RAS)
Offered through the Academic Center for Regulatory Affairs and Services
College of Science and Engineering, St. Cloud State University
145 Wick Science Building
Phone: 320.308.2167
Fax: 320.308.5124
Email: RAS@stcloudstate.edu
Web site: http://www.msras.com
Department Chair: Dr. David Degroote
Department Secretary:
Julie Nienaber
Director/Graduate Coordinator: Charles “Chuck” Swanson http://www.stcloudstate.edu/ras/about.asp
Graduate Faculty: http://www.stcloudstate.edu/ras/faculty.asp
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 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.
Program Overview
The graduate program provides the means to develop the essential understanding and competencies to work in the regulatory affairs of medical device manufacturers or consulting organizations. It provides experience and relevant training in three broad areas of regulatory affairs and services:
- Regulatory affairs
- Clinical trials and quality systems
- Health economics and reimbursement
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 at http://www.stcloudstate.edu/registrar/students/registration/non-degree.asp. 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.
Admission Requirements Specific to the Program
An undergraduate degree in engineering, biochemistry, biostatistics, public health, nursing or other appropriate and relevant areas is recommended as a basis for successful completion of the M.S. RAS degree. The director and selected instructors from the Academic Center for Regulatory Affairs and Services will review applications to ensure each candidate’s qualifications.
An important note:
International students on F-1 and J-1 visas cannot be considered for admission to the part-time Regulatory Affairs & ServicesAS program in Maple Grove, MN due to Immigration regulations. International students are only eligible for full-time degree seeking programs.
Length of Program – Measured by Semesters
- Part-time student: six semesters over two years.
Program location and time
The program is offered at the Maple Grove Graduate Center located in Maple Grove, Minnesota. For map/location, go online to: St. Cloud State University : Twin Cities Graduate Center
- 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.
Tuition costs: http://www.stcloudstate.edu/ras/apply.asp
To Apply
Visit the School of Graduate Studies Web site: http://www.stcloudstate.edu/graduatestudies/
The following Web sites provide admission requirements and a checklist for graduate admissions: http://bulletin.stcloudstate.edu/gb/admission/admission.asp#admintest
School of Graduate Studies
Telephone: 320.308.2113
Toll free: 1.800.369.4260
E-mail: graduatestudies@stcloudstate.edu
Master of Science in Regulatory Affairs and Services - 32 credits
Regulatory Affairs
RAS 621. Legal Basis for Medical Device Product Regulation, 3 credits
RAS 623. Investigational Medical Device Regulations, Standards, and Guidelines, 3 credits
RAS 625. Regulatory Submission/Application Requirements for Medical Devices: Routes to Market, 3 credits
RAS 627. International Regulatory Affairs: European Union, Canada, Japan, and Australia, 3 credits
Clinical Trials and Quality Systems
RAS 631. Clinical Study Design, Implementation, and Analysis, 3 credits
RAS 633. Quality Systems for Regulated Industries, 3 credits
RAS 635. Regulatory Affairs Compliance, 3 credits
Health Economics
RAS 641. Health Policy and the Medical Technology Industry, 3 credits
RAS 643. Cost Management of Regulated Health Care Technology, 3 credits
RAS 645. Reimbursement for Medical Technology, 3 credits
Culminating Experience
RAS 690. Regulatory Affairs Culminating Project, 2 credits
This course may be taken over one to three semesters, for a total of three credits. It is required for degree completion.
If you have further questions, please contact the College of Science and Engineering at 320.308.2167 or RAS@stcloudstate.edu
