QA/RA Certificate Helps CU Denver Students Stand Out in Competitive Biotech Job Market

As Colorado’s life sciences sector continues to surge, employers are seeking professionals who can navigate the complex regulatory and quality systems behind every medical device, pharmaceutical, and biotechnology product on the market. CU Denver’s Quality Assurance and Regulatory Affairs (QA/RA) Certificate—offered through the College of Engineering, Design and Computing—was designed to meet that demand.

For recent bioengineering graduate Abby Krohn, the certificate didn’t just teach industry skills—it helped her land her first full-time position in the medical device field three weeks before graduation.

“My overall experience in the Regulatory Affairs course was phenomenal,” she said. “I took the course as a senior at CU Denver and loved how applicable the course was to current events. It was so insightful and amazingly planned out it didn’t even feel like a class.”

Connecting Classroom Learning to Real-World Challenges

Developed from CU Denver’s well-established Regulatory Affairs course taught by Assistant Professor Chelsea Magin, PhD, the certificate blends classroom learning with hands-on experience. Students analyze current events in biotechnology, pharmaceuticals, and medical devices, applying classroom knowledge to real-world challenges.

“What stood out to me the most was when everyone shared a current event related to Regulatory Affairs in the biotech/medical device/pharmaceutical industries,” she said. “For me, it was amazing to see how what we learned in the classroom applied in the real world – and there are few courses I can say I ever took that had that impact on me.”

Taking the course during fall 2021, she also experienced a pivotal moment of clarity about how regulatory decisions affect public health.

“When I took the course, it was Fall of 2021 when there was still a lot of uncertainty surrounding COVD and the vaccines that were rolling out that year,” she said. “My biggest breakthrough was understanding how the process behind the FDA granting the Emergency Use Authorization of the COVID vaccines. It was incredible to see how the knowledge I gained in this class translated to real-life situations.”

Building Industry-Ready Skills

The certificate emphasizes practical, industry-aligned skills. One of the most significant tools she learned was how to navigate FDA databases—something she continues to use in her professional roles.

“Learning how to navigate the FDA’s website and see exactly how much information can be pulled from there was one of the biggest tools I learned in Dr. Magin’s class,” she said. “I’ve put this to use in every single role I’ve held in industry since!”

She also cites the mock 510(k) submission—an in-depth regulatory project that mirrors the process used to bring many medical devices to market—as one of the most impactful elements.

“The aspect of Dr. Magin’s class that impacted me the most was writing our own mock 510(k) submission,” she said. “It gave a really good taste of everything you need to think about when trying to get your device on the market.”

The course’s mix of team-based and independent work also mirrors professional environments.

“I also valued the balance of team-based vs independent work in the course,” Abby said. “After being in industry for 3 years, I can confidently say my work at all of my positions have been a similar breakdown of team vs independent activities as this course, and I feel this class strengthened these skills prior to going into industry.”

A Direct Path to Career Opportunities

Abby’s hands-on experience made an immediate difference in the job market. During interviews for a regulatory affairs specialist position at a global medical device company, her mock submission experience stood out.

“I 100 percent credit Dr. Magin’s course for getting me my first full-time job offer,” she said. “After I was hired, my manager told me that having the mock submission experience under my belt was what made me stand out from other candidates and ultimately landed me the offer letter.”

This certificate is a proven career accelerator; developed alongside with Colorado Bioscience Institute and more than 40 industry partners to fill the workforce gap in Colorado’s rapidly expanding life sciences sector. 

“Having a combination of QA & RA skills are highly, HIGHLY sought out in industry,” Krohn says. “Whether you’re looking to land a new position or grow in your current role, the knowledge you’ll gain from this course will be invaluable and only make you a more well-rounded professional.”

Preparing the Next Generation of Regulatory Leaders

Reflecting on the certificate that grew from the original course, Abby strongly encourages others to enroll.

“I would 100% recommend the new certificate program that has come from Dr. Magin’s course to someone looking to grow their career,” she said. “As I can attest, the skills I learned from this course not only landed me my first industry position, but I’ve continued to use this knowledge in every single position I have held since.”

As the life sciences industry continues to grow in Colorado and nationwide, CU Denver’s QA/RA Certificate is helping build the pipeline of professionals who ensure medical products are safe, effective, and ready for market. Through practical application, industry-relevant projects, and hands-on regulatory training, the certificate prepares students to launch and grow meaningful careers in a rapidly evolving field.

To learn more about the Quality Assurance and Regulatory Affairs Certificate, visit the College of Engineering, Design and Computing website.