In honor of RegEx’s 10-year anniversary, we are highlighting the most active members from the past 10 years! Follow along to learn more about these top community contributors.
Say hello to @Anne LeBlanc
Position: Regulatory Specialist
Employer: Mizuho Orthopedic Systems, Inc., manufacturer of specialty surgical tables and related products
What has been the highlight of your career over the last ten years?
There’s a cool device I did the operational design for back when I was working as an engineer. When I was transferred to a different group just as development was getting started, I felt devastated at first, but it ended up giving me more perspective. I had glimpses of the new engineers explaining my vision to each other as they worked out the details of implementing it. Then I overheard sales people talking about how the device works and how they communicate the features and benefits. Later, doing postmarket surveillance work on various products, I read about the very same device, with doctors explaining how they use those features to improve patient care. Fascinating feedback that I never got in the days when I was always immersed in the details of the next new product.
What makes you most excited about working in regulatory affairs?
I enjoy the variety and complexity of the work. I have opportunities to communicate with people around the globe in different languages. I read documents in many different styles. I get questions about chemistry, electronics, shipping, sterilization, diseases and injuries, environmental protection, packaging, metallurgy, surgical procedures, disabilities, risk, licenses, procedures, standards, data management, and who knows what all. I work with people having a mixture of goals, and help them agree on practical paths forward.
What is your #1 reason for becoming a RAPS member?
I entered the profession with a breadth of industry experience, but no formal regulatory background. Being responsible for my company’s regulatory positions, it was imperative that I begin by scoping out the extent of the relevant professional competencies, so I could prioritize filling my most critical knowledge gaps. RAPS was the obvious resource for knowledge about the profession itself.
What is your favorite part about RegEx?
It is fun to watch how knowledge grows. When one of us has a new, or new to them, regulatory problem, and asks the community for advice, there are usually several people with a little experience or a lot of expertise in related areas. As the participants add their thoughts, it builds a nice picture of the areas the original poster needs to become familiar with.
If you could travel anywhere in the world, where would you go?
There are so many people I’d like to visit, I couldn’t pick only one!
What food could you not live without?
Chocolate, of course. But broccoli is delightful, too, or anything fresh from the garden.
What is your go-to karaoke song?
The closest I’ve come to karaoke is a nearby manufacturer with an excessively loud exhaust system that would be really annoying except it sounds kind of like a bagpipe. It makes a fine drone for most of the Scottish songs I know.
What piece of advice would you tell yourself in 2011?
It’s not going to be perfect. You’re never going to have all the information. Trust your judgment and give it your best shot.
Favorite book you’ve read this year?
The Digger Omnibus, by Ursula Vernon. Bizarre and wonderful and hard to step away from.
What is one question you have for the RegEx community?
When you are speaking to someone who isn’t a regulatory professional, how do you describe your job?
Regulatory Affairs Professionals Society (RAPS)5635 Fishers Lane, Suite 400Rockville, Maryland 20852
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