Once in a while, we want to showcase the incredible people in our consulting group by digging under the CV to hear their stories and what motivates them to do the work they’re doing across the life sciences. A few months back, we showcased Neal Siegel, PhD, who shared his perspectives on system-level thinking, consent decree lessons, and what experienced quality leaders actually focus on when the stakes are high.
Today, we’re moving into the device and medtech space with Trey Thorsen, MS, RAC. Trey has worked as a regulatory consultant for six years now, and he’s clear about where his value lies in project work. His specialty is the 510(k) pathway itself, more than any single device category. That focus means he can step into almost any device project and know how to get it through the FDA. (We know because he’s done exactly that for many of our device clients!)
In this Consultant Spotlight, Trey sat down with us to talk about how he landed in regulatory work, the projects he likes best, and why he keeps coming back to The FDA Group. A few highlights from that conversation are below, but if device RA is part of your life (especially premarket notifications), we recommend watching this full conversation. Trey is a real talent in this niche.
From chemistry to regulatory affairs
Trey started in chemistry as an undergrad, then picked up a master’s in regulatory affairs. That combination, in his words, means he knows how to read and interpret FDA regulations. As he puts it, the work “is not rocket surgery.” It just takes someone who can translate what the agency is actually asking for.
Over roughly 15 years in medical devices, he worked for Class 1, Class 2, and Class 3 companies, which gave him a look at the full range of device risk classes. He eventually became director of regulatory and quality at a wound care device company. When that company decided to move manufacturing to Germany, the role went away. The managing director still wanted his regulatory help, though, and encouraged him to go out on his own. That is how the consulting work started. For Trey and his wife, he says, it was a “holy cow, what do I do now” moment.
Six years later, he’s still at it.
His sweet spot: 510(k)s and pre-subs
The work Trey likes best is easy for him to name: 510(k) submissions, regulatory strategy, and pre-submissions. He likes the part where a client shows up with a list of claims they want to make, and his job is to hold those claims against the predicate device and work out how much of the list is actually defensible. Sometimes, as he describes it, you can “work some magic and get everything you want together.”
He has a soft spot for orthopedics given his background.
“I think it’s really neat. I like to work with my hands, so I can understand it easily. I guess I should have been an engineer.”
Still, he doesn’t limit himself to one category. When a company wants a specialist in one exact device type, his response is that he may not be an expert in that specific device, but he is an expert in the 510(k) process. He knows how to read a standard and interpret an FDA guidance, and he knows what the agency needs to see. Not every consultant has that niche, and for most 510(k) work, knowing the pathway matters more than knowing the device. It’s why he tells clients he’s “comfortable being uncomfortable.”
Regulatory work isn’t magic
People outside the field, Trey says, tend to treat regulatory work like “voodoo,” something mysterious and a little intimidating. He pushes back on that idea a lot. The FDA rarely says things plainly in this area, so the job is mostly interpretation: read what the agency means, then put it in language a client team can actually act on.
Humor is part of how he does it. He likes to make clients laugh and put them at ease, because a client who trusts him will open up, and an open client is easier to help. He also treats the engagement as a partnership rather than a handoff, and he starts saying “we” with a client early on. “I’m invested in this with you,” as he puts it. If he doesn’t do his job, the client doesn’t get what they need, and that reflects on him and on The FDA Group, so he treats their outcome as his own.
Leave your personality at the door
Trey’s advice for anyone trying to break into regulatory consulting has less to do with regulations than with people.
You have to be ready for a wide range of client personalities, he says, from “I don’t know what I’m doing, please help me” to “I know exactly what I need, just do it.” Handling both takes patience and a thick skin.
He borrows a line from one of his old football coaches: “Leave your personality outside the locker room.” If a client says something that lands wrong, let it roll off, and do the job. Afterward, he jokes, you can go “cry or jump up and down or punch a bag,” whatever you need. The rest of his advice is simpler. When he doesn’t know something, he learns it, then uses it. “When the client’s successful, that means we’re successful, and we all grow together.”
Why he works with The FDA Group
Trey found us the direct way. When he first went independent and was hunting for work, he came across Nick Capman, our president and CEO, on LinkedIn. He sent a message asking whether The FDA Group had openings for consultants, got pointed to the right people, and has worked with a rotating cast of our team ever since.
Ask him why he stays and he’ll deadpan that it’s “surely not the personalities,” then admit the people are exactly the reason. He counts the colleagues he works with as friends, and that, he says, is what makes the work fun. That rapport tends to show on client calls.
A few lessons for consultants and in-house teams
For consultants and people moving into 510(k) work:
The pathway is the transferable skill, not the device. Trey worked across Class 1, 2, and 3 companies on purpose, and his argument is that knowing how to submit a 510(k), read a standard, and interpret an FDA guidance travels across device types in a way that deep knowledge of one device never will. Build range early instead of betting on a single niche.
Most of the job is interpretation and translation. His view is that regulatory work isn't hard so much as indirect. The work is reading what the agency means and then putting it in language a client can act on. Those are two distinct skills, and you need both.
When you don't know something, learn it and use it. He treats gaps as temporary rather than as reasons to pass on the work. That willingness to take on an unfamiliar device or requirement is what "comfortable being uncomfortable" looks like in practice.
For client teams choosing and working with a 510(k) consultant:
You may not need the exact specialist you think you need. Both Trey and our team see clients show up certain they need someone who has done their precise device, then realize after one conversation that what they need is someone who knows the 510(k) process cold. Screen for pathway fluency, not just a matching device on a résumé or CV.
Bring your claims early and expect a reality check. Trey's first move with a list of claims is to test it against the predicate and tell you what you can and can't defensibly say. A consultant who pushes back on claims up front is saving you from a deficiency later; one who nods along to everything is not.
Look for someone who translates, not just files. The value is a consultant who tells you what the FDA is really asking for and says it in plain terms. If you come off a call more confused than when you started, that is a signal.
Expect a partner, not a vendor. Trey treats your clearance as his own outcome, partly because the work reflects on him and on The FDA Group. That "we" framing is the difference between someone processing your paperwork and someone invested in getting the device through.
Talk to us if you need expert 510(k) support.
Be sure to watch our other conversation with Trey:
Trey Thorsen, MS, RAC is a regulatory consultant with The FDA Group. He holds a master's in pharmaceutical and biomedical regulatory affairs from the University of Georgia, a graduate certificate in clinical trials design and management, and the RAC credential; his undergraduate degree is in chemistry. Across about 15 years in medical devices, six of them as a consultant, he has worked with Class 1, Class 2, and Class 3 companies. His device experience includes active implantables with MRI functionality, external therapeutic devices for pain, software-enabled devices, sterile and non-sterile wound care, compression devices, surgical booms and lights, and devices for incontinence. He also has experience with 513(g)s, pre-submissions, Certificates to Foreign Government (CFGs), UDI/GUDID implementation, and EU MDR technical file development and remediation.
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