Why regulatory affairs is like a bunch of 'mini-investigations’
Michelle Lott joined us at RAPS Convergence 2022 in Phoenix for a conversation about her path into regulatory affairs from forensic toxicology, her current role and her first RAPS Convergence experience. This conversation has been lightly edited for clarity.
How did you get into regulatory affairs?
When I started in medical devices — actually, when I started my career technically, period — regulatory affairs really wasn't even a thing to be when you grew up. So, for me, it just happened through a series of career choices and transitions. I started out in forensic toxicology and then I found myself with an opportunity in medical devices — and in internal audits, at that. In internal audits, you learn a little bit of everything about the regulations and ISO standards. And I had the privilege of working in a healthcare facility that had medical devices, pharmaceuticals and combination products. So, I really had my hand in everything right out of the gate for my first job in regulatory affairs.
What do you like about regulatory affairs?
Because I have a background in forensics and I started as an internal auditor, everything was like a little mini-investigation for me. And so, I felt like, in a way, I had been trained to think along those lines and it was a natural fit. And then just the deeper I got, the more I learned about the regulations and started putting it together in my head, the more I enjoyed communicating and translating what I understood the requirements to be into a functional reality.
What is your current role?
So, currently I am the principal and founder of Lean RAQA. It is my own regulatory and quality systems consulting business. Day-to-day, I wake up, see what's changed and ask: “What do I need to do? What do I need to prepare my clients for?" Then I mobilize my team to better serve our clients in the regulatory and quality space.
What do you get out of RAPS membership?
Now I rely on Regulatory Focus, the daily news updates. Sometimes I'll even get news from RAPS before FDA will publish it, or the same day the FDA publish it. So they're definitely working to keep the community informed.
I’ve seen your name pop up in Regulatory Exchange, RAPS’ online member community. What do you get out of participating there?
Earlier in my career, I really relied on it as a at least a weekly tool to see what other people were thinking about challenges I was having, posting questions I had. Now when I'm involved, it's a little bit more by trying to be helpful and answer other people's questions. People know each other from there as well. So, I think that that's another good way to connect.
Why did you get your RAC?
We talked about how when I got involved with regulatory, it really wasn't a thing to study or be in college. Similarly, when I started getting into corporate America jobs, the first job that I didn't get was because I didn't have a RAC. And, at the time, that had not been something that had been offered to me in some of my previous jobs.
What has your experience at RAPS Convergence been like?
Well, believe it or not, this is actually my first Convergence. So, this is just really been a wild ride. There is so much material and advantages, coursework to take advantage of. There are so many people that have known me from LinkedIn and I get stopped in the hallway. There's just such a natural community on top of the educational opportunities to take advantage of here.