Grace Charles explains the value of mentoring in regulatory affairs and moving from R&D to regulatory

Grace Charles is a senior regulatory affairs specialist at Saluda Medical in New South Wales, Australia. She joined us at RAPS Convergence 2022 for a chat about her career path in regulatory affairs, a mentor who’s helped her and more. This conversation has been lightly edited for clarity. 

Why are you interested in regulatory affairs? 

I don't know about you, but if you were getting a medical device put inside you, I’d make sure that it's safe and effective. And that's what regulatory affairs is about: Making sure the products that we use, whether it be in the medical space or pharmaceutical space, are safe for people—to help the patients in the end. I think it's important to have people in that space who are on the patient's side and want to make sure that they're getting the care that they need for a given disease, or prevention, and to be a part of that. But from the back room, if that makes sense, as opposed to being in the front with the patient. I think it's very important to have people on that warpath getting the new device, the new technology on the market.

What’s your current role and what are your responsibilities there?

I’m currently a senior regulatory affairs specialist. What my day looks like is reviewing technical documentation, whether it be protocols, reports, plans, compliance matrices for a given standard, and drafting regulatory submissions, whether it be for the US, pre-submissions or PMA supplements, or writing the technical documentation for MDR. I'm also giving regulatory advice when there’s a sudden change that we want to implement, whether it be to a product or to a manufacturing process. I'm there to listen and to try to put the pieces of the puzzle together and give an informed response. 

How did you get into regulatory affairs?

I've been in regulatory affairs for the last three years. I originally was working as an intern for an orthopedics company doing R&D work, working on custom implants. My manager at the time said, “Hey, I think for your full-time position, why don't you try reg affairs?” And I was thinking, “Oh no, is he saying I'm a failed engineer?” That's what I used to think about regulatory affairs. You know, you're not doing the technical content anymore. You're doing paperwork and writing things. But I thought, “You know what, I'll listen to what he has said and give it a go.” I gave it a go and turns out I was really good at it. And since then, I've been loving it, taking other roles, and trying to learn more about the profession. . 

What do you like about regulatory affairs?

I like how diverse it is. I didn't realize how diverse it could get. I just thought, “Oh, you'll be stuck with the same product doing the exact same thing every single day.” But every time I turn up to work, it's quite different. I'm fortunate to work in a company  where I get to work across different regions. We have a product or a system of products that work together, so looking into each of those products is very different. Working on the different submissions is also very different and unique, and the people that you get to work with are quite interesting. You get to work looking at the bigger picture, so you get to work cross-functionally. You don't just work, say if you're an electrical engineer, you're not just stuck in that same team, you're working with electrical software and firmware, mechanical, etc. Sothat makes the work even more exciting.

Have you ever had a mentor in regulatory affairs?

Fortunately, I have had a mentor thus far. She is on the other side of the spectrum. In a couple of years, she's planning to retire. She reminds me every day. That's been really helpful, someone who can be a sounding board for my ideas to make sure I'm on the same wavelength as her, or if I'm taking too conservative of an approach with something that we're trying to wrestle with at that point in time. It's also good to build my confidence as well, coming into this space, being a lot younger, and there's a lot of other people working in this space, I wasn't so confident to give my opinion. But with her in my corner, someone who I can go to after a meeting if I had a question or someone who is there to just encourage me and say, “Hey, that's a great question to ask.” That's been really helpful. So, I would recommend that everyone has a mentor, someone they can go to and get some advice, even life advice as well. It doesn't always have to be about work.

How did you become a RAPS member?

I found out about RAPS membership through work. Some of the more senior colleagues said that it's a great resource. There's different conferences you can go to, there's different webinars you can attend, different articles that come out. It's also a great community where you can ask different questions from people from all different companies all around the world and have a community in your corner. So, that's why I became a member, and the rest of our team did as well. And it's been a really great experience so far.

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A lot of the forums about MDR and the particular pain points that every company is going through, we thought we were the only ones that didn't think there's a light at the end of the tunnel. But to find out through the Regulatory Exchange that actually a lot of companies are on the same page, saying “We're struggling to understand the transition. Not sure if we're going to make the transition or if we're putting in the right documentation or interpreting GSPRs correctly.” That's been really helpful thus far.

What has your experience been like at RAPS Convergence?

This is my first time at Convergence, and my first time traveling in over two and a half years. I come from Australia, so a little bit far from here. I came as an opportunity to learn more. Part of my professional development is getting a better understanding of regulations and developing my skills there. So, that's one of the reasons I came. Looking at all the different workshops and the speakers. It's a great wealth of resources and knowledge that I could gain in such a short amount of time, and it's also an opportunity to network. In Australia, the pool of medical device companies is a bit small, so coming here and playing with the big boys and being able to hear their experiences and get connected on LinkedIn has been a great opportunity so far. I've really enjoyed it.