How Sequita Lindsey navigated her way across the US and into a ‘full circle’ regulatory career
Sequita Lindsey’s introduction to regulatory affairs came from a big company, in a move that transition out of manufacturing and into a role that allowed her to "understand what goes on behind the scenes." Now she works as a regulatory consultant in what she says was an unexpected career move, one that came after a career journey that led her to both coasts of the United States and has finally led her back to North Carolina, where she also works as an adjunct professor.
Sequita traced her career arc in an interview with RAPS, which we have lightly edited for clarity.
How did you find your way into regulatory?
I was working for Cook Medical, a large medical device company that specialized in endoscopy products, and I was working in the poly department. We manufactured dilators and catheters, where we would place balloons on the catheters which aided in the retrieval of stones. So that introduced me to the manufacturing of medical device products. I saw an internal opening for a regulatory affairs associate position within the company, so I decided to go for it, and that was three years after working in manufacturing. In 2007, I moved into regulatory affairs as a regulatory affairs associate.
When you moved into regulatory, what interested you about that first position?
Because I was still really young, I didn't know anything about medical devices other than the manufacturing part of things. I just thought, well, maybe this will give me the opportunity to move out of production. What would that look like for my future? It was a really good way, in my opinion, to understand what goes on behind the scenes. A product moves through manufacturing and then on to your store shelves or hospital rooms. But you don't know how it got there. It was really nice to go back to the development phase to understand the full lifecycle, “OK, this is how we got here.” When I saw that opportunity, I jumped on it.
What led you to your current role as a consultant?
I honestly did not think that I would be a consultant. I figured consulting was the endgame in a sense, maybe something I might do right before I retire to keep my mind sharp and keep abreast of the ever-changing industry. I navigated through my first opportunity at Cook Medical, left there and moved to Oregon for an opportunity at Acumed to learn another product portfolio, then came back to the East coast for another opportunity with Stryker where I was able to learn more about quality. At that point, I was in regulatory and quality as an RAQA specialist. I was able to learn a little bit about internal auditing and become certified. We decided to move back to North Carolina, where it all began, to bring things full circle. When I began working for Teleflex, I learned more about international registrations, more about Latin America, more about Asia-Pacific/Middle East, and more leadership and management. That’s what was driving me at that point. Unfortunately, I did have to leave to expand my career, but it was for an amazing opportunity to work for a small startup. As most of us know, at a small startup, you wear a lot of hats, and it was also my first experience with clinical trials. It was a really great experience. I hate that it did have to end, as startups a lot of times, do not make it to commercialization in the United States. Due to this, my time as the regulatory manager at Micell Technologies was over.
I guess something clicked in my brain and I said, “Well, maybe this is my opportunity to go into consulting instead of looking for another job in industry.” And that's what happened in 2018, the creation of Lindsey Regulatory Affairs Consulting, LLC. I created a consulting firm, and it really was a big boom around that time, because EU MDR was really heavy for a lot of companies, and it gave me the opportunity to work with a lot of clients with various product portfolios. It was a wild time during that phase of getting EU MDR certified for a lot of clients. But then, of course, Covid hit, and that really took a toll on a lot of companies and clients that we were working with. But, as we all know, we all bounced back, and we had more opportunities because the world of medical devices and pharmaceuticals doesn’t stop, and you still need projects to be completed.
What is the most exciting or challenging part of your job right now?
Regulations and guidances always changing. Regulations are always being updated. That's probably the biggest challenge: making sure that we're interpreting regulations in a manner that is easy for the client to understand so they know what they need to do to be compliant. But the exciting thing is that maybe it's something brand new, a new territory that we don't have much background on; we're all learning, and I wholeheartedly feel FDA and other health authorities give you the opportunity to ask questions and get a better understanding of where they're coming from and their stance, as we all prioritize patient safety and push for timely approvals of life-saving products.
You also work as an adjunct professor. What inspired you to get into the teaching side of things?
I did not think that I would ever be in academia. It's not anything that I was ever like, “let me check that off my list.” I was actually doing a career spotlight series with Durham Tech. The coordinator there asked me if I could speak about my career because they have a clinical trials research associates degree program there. Also, because I am a member of Black Women in Clinical Research, they wanted to get my perspective on what it's like being in clinical research and regulatory affairs. A lot of times — not to say regulatory affairs doesn't get enough recognition, we do — it can be outshone by the clinical research part of things right when we're thinking about new product development and new drug development. I completed my highlight series, and she reached out and said, “Hey, North Carolina Central University has a regulatory science course and the instructor is leaving. You may be good for this."
How does your RAPS membership help you?
I've been a RAPS member for almost 20 years. When I first entered into regulatory, I was able to obtain my Regulatory Affairs Certificate before I went on to earn my Regulatory Affairs Certification in global scope. All of the modules, the webinar opportunities, and other education opportunities were so beneficial for me.
Going to RAPS Convergence, participating in speaking engagements and other conferences is key to my networking ability. Just having a space for regulatory professionals is so great. Speaking with individuals who could possibly be my future mentors, and now maybe speaking to students who could be future mentees. That was one opportunity in particular that I really liked, and I like that that RAPS has the mentoring program now, too. As a mentor and mentee, this opportunity is invaluable.
Since this interview was conducted, Sequita Lindsey has transitioned into a new role at BD as the senior manager of regulatory affairs, infection prevention.