There is a demand for professionals who can navigate the complexity of a multidisciplinary field that uses scientific research to make safe and effective medical products available to patients worldwide. These professionals ensure compliance with state, federal, and international medical device regulations for safety and efficacy.

Designed by industry experts, the program provides extensive knowledge and skills in a convenient setting at St. Cloud State at Plymouth or synchronously online through Zoom. All courses are taught by regulatory leaders with extensive practical experience working for medical device diagnostic companies.

This is the only master's program in the United States focusing on medical device regulation. It provides greater depth than other programs covering pharmaceutical and biologic regulations. A graduate certificate is also available.

Regulatory Affairs and Services is a STEM-recognized program for Optional Practical Training (OPT). 

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The demand for professionals with advanced regulatory science competencies and skills is increasing as medical technology increases in complexity. Regulatory affairs is one of the most in-demand professions in the medical device industry. Regulatory affairs opportunities include the Food and Drug Administration (FDA) or international pre-market submissions, post-market surveillance and regulatory compliance roles in the workplace. Graduates of the program have gone on to work for 3M, Medtronic, Boston Scientific and the FDA. 

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:

• Science and engineering
• State, federal and international regulations
• Planning and risk management
• Business development/corporate strategy

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 a workforce with regulatory science competencies and skills is growing significantly.

Industry facts

• 22% of employees in the greater Twin Cities area work in the medtech sector
• 600+ life science and medical companies operate in Minnesota

Medtech profession news

• Minnesota's Life Science Ecosytem Retains World-Class Status
• Top 40 Medical Device Companies (in MN Medical Alley)
• Minneapolis/St. Paul Medical Device News
• Minnesota MedTech 3.0

Internship/Portfolio Track

Students on this track can complete the program in as little as two years and meet the requirement to build a portfolio of experience (i.e. via an industry internship, co-op, or contract). To maintain full-time status, a student must be enrolled in a minimum of 8 credits in their first semester and 6 cr. in subsequent fall and spring terms.

The internship/portfolio track encourages students to apply what they have learned in coursework through goals setting and coaching by regulatory faculty in a variety of medical device engineering project capacities

Capstone Track

Professionals on this track pursue this degree for professional development purposes. Courses are offered on weekday evenings outside of traditional business hours. The program can be completed by attending most of it online synchronously.

A culminating project is completed with their employer. Each student uniquely applies what they have learned in their course work to advance their leadership and mastery of regulatory science principles to product, process, new requirements, or business initiatives.