Science drew me to regulatory affairs. Here's what helped me find my niche.
A career in regulatory affairs can start, or end, just about anywhere. At RAPS, we’re dedicated to showing you the possibilities a career in regulatory affairs can give you. In this blog, Raquel Peregrino de Brito, regulatory affairs supervisor at Solventum, explains how she transitioned from dentistry to project management, then to regulatory affairs. She told us about her experience, with a nod to the critical role the RAPS Certificate in Medical Device Regulations played along the way.
Like so many of us in regulatory affairs, my career has taken a few twists and turns to get to where I am now.
After dental school, I spent four years as a practicing dentist in Sao Paulo, Brazil. But when life brought me to the United States, I decided a career change was in order.
After a job as an interpreter led me to a company that worked in regulatory processes for transmitters, I joined a company that made dental medical devices. That connected me to my dental roots, and it was also where I was first exposed to regulatory affairs for medical devices.
Regulatory affairs had a huge learning curve, but that's part of what made it worthwhile
The unique scientific aspect of this field is what drew me to regulatory affairs. You have a standard you have to meet, and you have to prove that you’ve met it, and you need all these documents to support your claims. I just thought it was really interesting.
But the transition to medical devices was such a huge learning curve for me. Not only was I learning about regulations and the FDA, but I was learning the basics of the medical device industry at the same time.
I remember we had a minor nonconformity that said, "You don't really have a clinical evaluation report for these devices." I thought, “I don't even know what a clinical evaluation report is.”
Still, everything was super interesting and I kept wondering, “Where can I learn more about this?”
Regulatory affairs had a lot of skills that were transferable from my previous roles, but a huge part of my training early in my career started with the online certificate program from RAPS.
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The RAPS Certificate in Medical Device Regulations gave me a stable foundation for my regulatory affairs career
My manager at the time recommended that I take the RAPS Certificate in Medical Device Regulations, so a colleague and I took it together.
We really went on a journey, the two of us. We completed a lesson or two each week, then exchanged notes.
It was really a great program. It gives you the foundation to know what you’re doing in regulatory affairs. It helped me learn the basics for a QMS system, to just use one example. The entire certificate program gave me really good fundamentals to understand important regulatory concepts.
The program also really fit my work schedule at the time. My colleague and I liked finishing lessons in one sitting whenever we could, so we would block out two or three hours to try to finish a whole lesson in a day.
Plus, the self-paced program makes it really easy to fit into your day, because you can just pick up where you left off.
The knowledge I gained also started my journey to earn my RAC a few years later and my RCC a few years after that. My learning continues as I plan my own professional development each year, to stay updated with industry changes.
Now that I’m a manager, I recommend this foundational regulatory education for new staff
As a leader in regulatory operations at Solventum, my goal is to develop my team. One of the first things I had my new staff do was sign up for this certificate program.
You can use all the technology in the world to help you make decisions these days. But to develop sound regulatory judgement, you need that baseline knowledge from a trustworthy source. It’s super important to have that knowledge first before you go in and perform the serious work regulatory professionals do.
