Regulatory Affairs and Services
General
Program Title
Regulatory Affairs and Services
Degree Designation
MS
Award Type
Masters
Program Level
Graduate
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.
Department/Unit(s)
College/School
College of Science and Engineering
Status
Active
Admission Requirements
What previous degree and/or experience is required prior to admission to this program?
Bachelors Degree
Minimum undergraduate GPA for admission
2.75
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.
Requirements
Program Learning Outcomes
Outcome
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.
Outcome
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.
Outcome
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.
Outcome
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.
Outcome
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
Major Code
8099
Program Code
7555