Regulatory Affairs Certificate

Certificate Overview

With this flexible, accelerated program, you can earn your certificate in Regulatory Affairs from top Colorado State University faculty and experts from the medical device and pharmaceutical industries. The Regulatory Affairs Certificate program was developed by CSU's renowned School of Biomedical Engineering in collaboration with the Regulatory Affairs Industry/Academic Consortium (pdf) in response to the rising demand from the medical devices and pharmaceuticals industries. This four-course certificate program provides a comprehensive understanding of the central elements of regulatory affairs as it applies to the development and commercialization of these products.

Regulatory affairs management is a rapidly growing field. The number of regulatory affairs managers in Colorado is expected to grow 17% by 2016 to about 22,500 workers. Nationally, employment opportunities for regulatory affairs managers are expected to grow by about 7.3%. Regulatory affairs managers earn about $47 hourly or $99,360 annually on average in Colorado and about $43 hourly or $90,230 annually on average in the U.S. as a whole. (Source: Career and Education Opportunities for Regulatory Affairs Managers in Colorado)

The courses in this program prepare you for work as a regulatory affairs professional in the medical device, in-vitro diagnostic, tissue, or pharmaceutical industries in specialized roles, such as regulatory affairs manager, pharmaceutical quality assurance manager, quality assurance director, and quality assurance supervisor.

The courses in this certificate program also help professionals prepare for the Regulatory Affairs Certification (RAC) Exam by the Regulatory Affairs Professional Society (RAPS).

Requirements and Curriculum

The Regulatory Affairs Certificate is comprised of three tracks:

• Medical Devices, In-Vitro Diagnostics (IVD), and Tissue Products
• Drug and Biologics
• Clinical Trials Management

Each track consists of four courses, two required courses and two elective courses, so you can design a customized certificate that meets your professional needs and interests. You have the option to take one or more individual courses as needed to fit your educational and employment goals, though you will not be issued a Certificate of Completion.

Admission to Colorado State University is not required to register for these courses or to complete a certificate.

Required Courses (minimum of two courses)

Medical Device, IVD, and Tissue Industry

Drug and Biologics

Clinical Trials Management

Electives (two courses required)