Regulatory Affairs and Services


Program Title

Regulatory Affairs and Services

Degree Designation


Award Type


Program Level


Instruction Mode

On Campus

Program Description

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


College of Science and Engineering



Admission Requirements

What previous degree and/or experience is required prior to admission to this program?

Bachelors Degree

Minimum undergraduate GPA for admission


Other requirements applicants MUST complete prior to admission.

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 GRE is not required.


Program Learning Outcomes


Obtain and apply broad knowledge of domestic and international law, regulations, and guidance documents covering pre- and postmarket requirements for at least one category of medical products, including combination products.


Examine quality systems and standards and their impact on product and public safety as well as the importance of quality products from the perspective of healthcare providers.


Obtain and apply broad knowledge of US Food and Drug Administration (FDA) and international requirements for the approval and conduct of pre- and postmarket clinical studies with regulated products. Understand the basic principles of clinical study design and clinical data analysis.


Recognize the factors that influence domestic and international regulatory decisions. Develop methods to incorporate regulatory trends and practices. Think strategically about product development, market approvals and marketing.


Develop interpersonal, critical thinking and interpretation skills. Develop written and oral communication skills, with the scope and flexibility to address audiences with differing size, knowledge and priorities. Write and present clearly and concisely in an audience-appropriate manner.

Degree Maps

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