Regulatory Affairs and Services MS

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.