Explore CU Denver Programs
Use the search tool below to discover degree and certificate programs offered by CU Denver. If you are unable to find a program that is right for you, please contact Admissions or a school or college for more information.
Program Overview
The Quality Assurance and Regulatory Affairs (QA/RA) Certificate Program is an interdisciplinary program designed to upskill or reskill aspiring or working professionals interested in expanding their knowledge of how to bring a medical product to market including regulations, quality management systems, risk management, compliance, auditing and inspection metrics, design controls, and best practices.
The Quality Assurance & Regulatory Affairs (QA/RA) Certificate at CU Denver prepares students for in-demand careers in the life sciences, biotechnology, and medical device industries. This interdisciplinary program provides essential knowledge in regulatory strategy, quality systems, risk management, and compliance, ensuring that medical products meet rigorous standards throughout development and commercialization.
Developed in partnership with industry leaders and the Colorado BioScience Institute, the curriculum combines online coursework with a hands-on capstone experience at Denver-area companies. Learners gain practical skills, mentorship, and professional connections that position them to contribute immediately to their organizations. The program is flexible and accessible to professionals seeking to upskill or enter the QA/RA field without committing to a full degree program.
Program Description
The Quality Assurance & Regulatory Affairs (QA/RA) Certificate at CU Denver prepares students for in-demand careers in the life sciences, biotechnology, and medical device industries. This interdisciplinary program provides essential knowledge in regulatory strategy, quality systems, risk management, and compliance, ensuring that medical products meet rigorous standards throughout development and commercialization.
Developed in partnership with industry leaders and the Colorado BioScience Institute, the curriculum combines online coursework with a hands-on capstone experience at Denver-area companies. Learners gain practical skills, mentorship, and professional connections that position them to contribute immediately to their organizations. The program is flexible and accessible to professionals seeking to upskill or enter the QA/RA field without committing to a full degree program.
Program Benefits
Industry-Aligned Curriculum
Developed with input from over 16 regional life sciences companies, ensuring coursework meets the real-world needs of employers.
Flexible Online Learning
Four fully online, asynchronous courses allow students to balance professional and personal commitments.
Hands-On Capstone
A 3-day in-person immersive experience at Denver-area companies provides practical, real-world application of QA/RA skills.
Mentorship & Networking
Students receive guidance from industry professionals and access to job-matching resources through the Colorado BioScience Institute.
Career-Focused Outcomes
Graduates are prepared for high-demand roles such as Regulatory Affairs Specialist, Quality Assurance Associate, Compliance Manager, and Design Control Coordinator.
Stackable Credentials
Courses can count as micro-credentials that build toward the full certificate, supporting both professional development and lifelong learning.
Program Features
12
credit hours
Fall/Spring
starting semesters
Online
classes
Mentorship/Job-matching resources
through the Colorado Bioscience Institute