7555 - Regulatory Affairs and Services

General

Program Title
Regulatory Affairs and Services
Degree Designation
MS
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(s)
Applied Education in MedTech Industry
College/School
College of Science and Engineering
Status
Active

Requirements

Learning Outcomes

Objective
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.
Objective
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.
Objective
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.
Objective
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.
Objective
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