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This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Principal Regulatory Affairs Strategist at Canon Medical Informatics
Minnetonka, MN (remote from Irvine, CA)
RAC holder since October 2021
Like many others, I landed in regulatory affairs by chance. Unlike most others, I started out as a quantum mechanic. I was trained as a theoretical physicist, a field where jobs are few and far between. By the end of my first year as an assistant professor, in a small town three hours from an international airport, I had begun to entertain the possibility that my life might require more geographic flexibility than an academic physics career offered.
Just then, a friend told me the US Food and Drug Administration (FDA) was hiring physicists. At the time, a hot regulatory issue in medical imaging was how to evaluate labeling claims that software algorithms associated with CT could reduce radiation dose to patients. With my background in math and programming, I had the necessary skillset. So, 11 years ago I took a deep breath, and I gave up a tenure-track position, jumping from quantum mechanics into medical imaging, from basic to applied science, and from research into regulatory. I enjoy regulatory work because I like science, I like to write, and as a PhD physicist, I like to come up with creative strategies to solve problems. It’s also a thrill to visit a hospital and see devices in use that I played a role in bringing onto the US market. You don’t get that in quantum mechanics.
I might be at a workstation processing medical images, or I might be writing a regulatory submission, or I might be in a global meeting with clinical personnel. But one of the things I enjoy about my career is that there has been no typical day: as a regulatory scientist, I keep one foot in the technical world and one in regulatory—and have gone back and forth a few times.
I spent several years managing translational research. One project involved transporting human cadaveric specimens for medical imaging at a hospital on the West Coast. Unfortunately, there was a last-minute snafu: when the refrigerated truck was about to arrive on site, we were told that it could not unload. We had to think fast and make last second plans to divert the specimens to an alternate site. It all worked out, and in September 2021, the resulting image appeared on the cover of "Physics Today." Only a few people know how close the image came to not happening!
Regulatory offers different career paths. Talk to people in a variety of places (industry, government, hospitals, consulting) so that you understand all of your options. In industry, regulatory experience can also open paths into regulatory-adjacent roles like product management, clinical affairs, or R&D.