Why regulatory professionals are storytellers
Irma Sandoval-Watt, regulatory affairs manager at Philips and a RAPS member since 2010, joined us at RAPS Convergence 2022 in Phoenix, Arizona for a chat on her career path and much more. This interview has been lightly edited for clarity.
How did you get into regulatory affairs?
In 2001, I actually saw a training that said, “Regulatory 101.” I was in quality, so I started asking questions. I actually went to the first RAPS Convergence after 9/11 and learned a lot about regulatory. And I was really kind of inspired. A new area to search and to grow my career. And that’s how I got into it.
What was your first job in regulatory affairs?
I actually was doing a 510(k) for an IVD product — and I didn't know anything about a 510(k). I just prepared and went to the interview knowing that I had no idea. I used to work in pharmaceuticals, so then I made the transition to medical devices and regulatory at the same time. So when I did that transition, I kind of trained myself, went and read and then I went to the interview and I got the job.
What do you do now?
So now I'm a regulatory manager. I have done IVDs, combination products, drugs, devices and now I’m in software as a medical device. So I'm seeing an array of types of devices and I'm leading three devices through EU MDR and any submission that they might want and any new product coming into the pipeline in software as a medical device.
What’s one thing you like about your current role?
Well, one would be to actually be with R&D and working through the problems and explaining to them why documentation and traceability is so necessary. We're storytellers. We have to tell the story of how this product went from point A to point Z. How we do that shouldn't be tribal knowledge. It should be documentation telling you, when was it tested? Who tested it? How did it happen? And so on and so forth.
And that story needs to be documented and told. So for me, the best part is making somebody aware that that is the need for me to ask for 20,000 documents. It's telling the story without us being there.
Why do you think the regulatory profession is important?
First of all, we need regulations. We're a regulated industry. We have to have all these guidances and rails to stay within. We need somebody to interpret those and that understands also the manufacturing side so we can translate what is done in the manufacturing and how can we stay within compliance. The profession is amazing. It's never the same thing twice. Very exciting sometimes. I enjoy it because it's like you're putting a puzzle all the time and it's never the same puzzle.
Why are you a RAPS member?
Oh, RAPS. Well, definitely a lot of knowledge, a lot of camaraderie and a lot of networking. The networking is the most important thing, because I'm always learning something and my network starts growing in which I can call somebody and say, you know, “I don't know how to read this. Can you can you give me a second look into the regulations? How do you handle it?” It's a second set of eyes and it's priceless, truly.
Why did you decide to get your RAC?
Well, I wanted to move forward in my profession. And the RAC gave me the opportunity to review all the regulations from devices, drugs, biologics and other areas that I hadn’t worked in and gave me that big perspective, like the higher vision, right? And it was hard. But I'm so grateful for it. I get recruiters calling me just because I have the RAC and they know how much it means.
What was your RAC exam experience like?
It was hard. I had to study after work for six months, going to the library and telling my family, “See you later. I have to go to study.” It wasn't easy. The questions were, sometimes it was the best two things and you couldn't tell which one was the right one. It was just a gut feeling. Sometimes this career is a little bit of gut feeling. My spidey sense says we should go this way, and that's where we go.
What’s one highlight from your RAPS Convergence 2022 experience?
It has been very positive. I have met many more people this time. Oh, this is the one thing I learned this time. I'm not technologically savvy. We don't have a business card, and what somebody taught me is how to connect with somebody through a QR code. And for me that was priceless.