Regulatory Affairs Certificate

Certificate Overview

The Regulatory Affairs Certificate Program is not currently accepting new students.

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).

Our Students

Students who have attended our certificate program are employed by the following organizations (partial list):

  • Amgen
  • Bard Medical
  • Baxter
  • BioMARC
  • Clinipace Worldwide
  • Cochlear Americas
  • Covidien
  • Dannon
  • Genetech
  • Lion's Eye Bank
  • Medtronic Navigation
  • Pharmatech Oncology
  • Reglera
  • Sandoz
  • Terumo BCT
  • Tolmar