Regulatory Affairs and Services Graduate Program (RAS)
Offered through the Academic Center for Applied Education in the MedTech Industry
College of Science and Engineering, St. Cloud State University
145 Wick Science Building
Web site: http://www.stcloudstate.edu/medtech
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 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.
This program focuses on the specific educational needs related to required regulatory approval in the Medical Device industry. 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.
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.
Please note: Graduate special students 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 special students. All special 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 special student 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 special student 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. Students cannot complete any graduate degree program through this registration category.
Admission Requirements Specific to the Program
- For admission consideration to the program, a candidate must first meet the minimum GPA admission requirements of the School of Graduate Studies at St. Cloud State University.
- The GRE is not required.
- 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.
- 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.
Application Deadlines Specific to the Program
Visit the School of Graduate Studies Web site
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
Toll free: 1.800.369.4260
Length of Program – Measured by Semesters
- Part-time student: six semesters over two years.
Program Location and Time
The program is offered at the Twin Cities 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
Master of Science in Regulatory Affairs and Services - 33 credits
RAS 621. Legal Basis for Medical Device Product Regulation, 3 credits
RAS 623. Regulatory Routes to Market: 501(k)s, 3 credits
RAS 625. Regulatory Routes to Market: PMA's, 3 credits
RAS 627. International Regulatory Affairs: European Union, Eastern Europe, Australia and Canada, 3 credits
RAS 631. IDE Regulations and Clinical Trial Design, 4 credits
RAS 633. Quality Systems for Regulated Industries, 3 credits
RAS 635. Regulatory Affairs Compliance, 3 credits
RAS 641. Health Policy and the Medical Technology Industry, 3 credits OR RAS 643. Reimbursement and Cost Management for Medical Technology, 3 credits
RAS 690. Regulatory Affairs Culminating Project, 2 credits
RAS 651. Regulation
of Combination Products, 3 credits
RAS 653. Regulatory and Clinical Ethics Involving Medical Devices, 3 credits
RAS 655. International Regulatory Affairs: Japan, Other Asia, South America and Middle East, 3 credits
RAS 657. Advanced Reimbursement and Cost management for Medical Technology, 3 credits
If you have further questions, please contact the College of Science and Engineering at 320.308.2167 or RAS@stcloudstate.edu