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Graduate Certificate: Quality Assurance and Regulatory Affairs
College of Engineering, Design and Computing
Overview
Degree: Credit available Graduate Certificate
Classroom Type: Fully Online
Department: Bioengineering (CEAS)
Are you looking to launch or level up your career in the booming biotech industry? Our interdisciplinary certificate program is designed to give you the exact skills employers are looking for. QA/RA professionals are the experts who ensure medical products are safe, effective, and compliant with regulations. While these roles are in high demand, they are often the hardest for companies to fill, meaning there is a massive opportunity for you to step into a high-wage, high-skill career.
Application deadlines
August 10, 2026
Built for Your Schedule: Courses are delivered online and asynchronously, allowing you to learn whenever works best for you.
Real-World Experience: The final capstone includes a 3-day, in-person experience hosted by industry leaders right here in the Denver Metro area.
Industry Connections & Expert Curriculum: Gain access to mentorship, job-matching activities, and a network of over 16 industry partners through the Colorado BioScience Institute. Our courses are designed alongside an Advisory Board of biotech leaders to ensure you learn the most relevant, up-to-date best practices.
Program Details
Interest Categories: Healthcare Science & Technology
Campus: CU Denver
| Program Details | |
| Dates | Fall program begins August 17, 2026 |
| Format | 100% online, plus a 3-day in-person capstone experience in Denver |
| Duration | 4 course |
| Cost | $7,800 |
| Credits available | 12 |
What You’ll Learn
-
BIOE 4054/5054 - Introduction to Regulatory Affairs
4 credits
Course Details
Master the rules of bringing medical products to market. -
BIOE 4055/5055 - Introduction to Quality Assurance
4 credits
Course Details
Learn how to manage quality systems and standards. -
BIOE 4094/5094 - Post-market QA/RA
4 credits
Course Details
Navigate compliance and safety after a product has launched.
-
BIOE 4095/5095 - Product Lifecycle Capstone
4 credits
Course Details
Apply your skills in a hands-on, real-world setting.
Recommended Completion Time:12 credit hours
Required Credits for Completion:12
Admission Requirements
Who Should Apply?
We value both education and hands-on experience. You are eligible if you have:
● A Bachelor’s degree (minimum 3.0 GPA), OR
● Four years of experience in a regulated manufacturing environment, OR
● A combination of both (for example: a two-year degree plus two years of work experience.)
Financial Support & Scholarships
You may be eligible to attend for free! Through the NSF ExLENT PIVOTS program, non-degree-seeking students can apply for full tuition support plus a $2,500 stipend. This funding is specifically designed to help people move from lower-wage roles into professional biotech careers by removing financial barriers. If you are looking for a fresh start in a new field, we encourage you to apply.
- Scholarship Deadline: July 15, 2026
- Program Application Deadline: August 10, 2026
Ready to get started?
Don't let the technical jargon hold you back. We are here to help you navigate the application process.
- Apply through the NSF Portal (For Scholarship Seekers): https://etap.nsf.gov/award/8280/opportunity/11360
- Apply through the University Portal: https://www.ucdenver.edu/admissions/graduate
Questions? Reach out to the Department of Biomedical Engineering:
Email: [email protected]
Phone: 303-724-9972