At MedQAIR, we know that strong regulatory and quality systems are built on both experience and continuous learning. As medical devices, software, and AI-enabled technologies become more complex, the industry needs professionals who can combine scientific thinking, attention to detail, and a commitment to patient safety.
We are pleased to introduce Lauren Perez, Jr. Quality & Regulatory Consultant at MedQAIR. Lauren recently graduated from Radboud University with a degree in Biomedical Sciences and brings a strong foundation in research, data analysis, and evidence-based decision-making.
As she begins her career in the medical device industry, Lauren is developing her expertise in quality and regulatory affairs while supporting MedQAIR’s mission to help manufacturers navigate complex compliance requirements.
We asked Lauren about her academic background, her interest in healthcare innovation, and what attracted her to the field of regulatory affairs.
1. Can you tell us a little about yourself and your academic background?
I grew up with a real curiosity about how the human body works and how science can be applied to improve people’s lives. That curiosity led me to pursue a master’s in Biomedical Sciences at Radboud University in the Netherlands, where I spent 2 years building a foundation in everything from cell biology and physiology to research methodology and data analysis.
Radboud has a strong emphasis on evidence-based thinking, which I think has shaped how I approach problems. I always want to understand the ‘why’ behind things. Graduating and stepping into the professional world feels like an exciting next chapter, and I’m grateful to be starting it at MedQAIR.
2. What led you to study Biomedical Sciences?
Honestly, I was one of those students who couldn’t choose between biology, chemistry, and the more human side of medicine. Biomedical sciences felt like the perfect intersection of all three. I was also drawn to the idea that the field sits so close to real clinical impact. You’re studying science where the knowledge connects directly to patients and treatments. That felt meaningful to me from the start.
3. During your studies, were there any subjects or research projects that particularly interested you?
A module on medical technology and biomaterials stood out for me because it was the first time I felt the direct link between bench science and clinical application. We looked at how materials behave in the body, how devices are designed around biological constraints, and what can go wrong. It sparked an interest in the broader ecosystem around how medical products are developed, tested, and brought to market
4. What attracted you to a career in quality and regulatory affairs?
I wanted a role where scientific knowledge directly shapes outcomes, but not necessarily in a lab setting. Regulatory affairs felt like a place where you could apply critical thinking and evidence-based reasoning to real-world problems at a systems level. The idea of helping ensure that safe, effective technologies actually reach patients felt very meaningful to me.
5. How do you think your background in biomedical research helps you in your current role?
More than I expected, actually. A lot of my role involves reading and critically assessing scientific and clinical evidence. From understanding study designs, evaluating claims, and spotting when data does or doesn’t support a conclusion. My degree trained me to do exactly that. I’m also comfortable working with structured documentation and thinking systematically, which is essential in quality management. The mindset of ‘show your evidence’ that was drilled into us at university translates very naturally here.
6. What excites you most about working in the medical device and healthcare sector?
The fact that it’s never static. The regulatory landscape around software as a medical device and AI-enabled technologies is evolving rapidly, and I find it genuinely exciting to be entering the field at this moment. There’s also something grounding about knowing that the work has a direct connection to patient safety.
7. What has been the biggest learning experience since joining MedQAIR?
The pace and variety, honestly. Coming from an academic environment where you might spend months focused on a single project, consultancy is a different rhythm entirely. You can be working across multiple clients and different device types in the same week. It was a lot to adjust to at first, and honestly, I am still adjusting, but I’ve come to really enjoy it. It keeps you sharp and forces you to build knowledge quickly.
8. Is there a particular area of regulatory affairs, quality management, or medical technology that you would like to explore further?
I’m especially interested in the regulatory frameworks around AI and software as a medical device. It’s an area where I think the rules are still being written in many ways, and I find that intellectually exciting. I’d like to develop a deeper understanding of how regulators are approaching algorithm-driven technologies.
9. What do you enjoy most about working with the MedQAIR team so far?
The combination of expertise and openness. Everyone I’ve worked with brings deep knowledge, but there’s no sense of hierarchy around ideas. Questions are welcomed, and I never feel like I’m supposed to already know everything. That kind of environment makes learning feel safe, which I think is exactly what you need when you’re starting.
10. What skills or qualities do you hope to develop over the next few years in your career?
I want to build genuine in-depth knowledge in technical regulatory strategy. I would also like to strengthen my communication skills, particularly around translating complex regulatory requirements into clear guidance for people who aren’t specialists.
11. Outside of work, what are some of your hobbies or interests?
I personally consider myself to be a creative person. A lot of my hobbies revolve around arts and crafts. Whether that be drawing, crochet, or pottery. Aside from those, I enjoy reading.
12. If you could give one piece of advice to students or recent graduates considering a career in healthcare, science, or regulatory affairs, what would it be?
Don’t wait until you feel fully ready. I think there’s a tendency, especially in fields that feel very technical, to believe you need to know more before you can contribute. But a lot of the learning happens by doing, by asking questions in real situations, and by being willing to be a beginner in public. Find an environment where that’s encouraged, and then lean into it.
The Wrap
Lauren’s journey into quality and regulatory affairs is just beginning, but her strong scientific foundation, curiosity, and evidence-based approach already align closely with the work we do at MedQAIR.
As medical devices, software, and AI-enabled technologies continue to evolve, the industry needs professionals who can combine technical understanding with a commitment to quality, compliance, and patient safety. Lauren brings that mindset to her role and is developing the knowledge and experience needed to support manufacturers navigating an increasingly complex regulatory landscape.
We are excited to have Lauren as part of the MedQAIR team and look forward to supporting her growth as she builds her career in regulatory and quality affairs.
Behind every regulatory strategy is a team of dedicated professionals. If you’re looking for support with medical devices, SaMD, or AI compliance, get in touch with MedQAIR to see how we can help.
