How I Broke Into Regulatory Affairs, and How You Can Too

My very first blog post on my website was part one of a two-part series explaining why I do what I do, and how I got where I am. I recently gave a talk at Enventure in Houston where I fielded a lot of questions about this topic, so I think it's a good time to share this information again. Below you'll find both blog posts consolidated into one.

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For a variety of reasons I really wanted my first post to explain how I got where I am, and why. I love what I do, and it's important to me that my clients understand that passion and my motivation.

I earned my B.A. in Molecular Cell Biology, then went on to work on my PhD in Neuroscience. Around my third year of grad school, I realized that while I really liked the bench (and my research), I felt disconnected from people and too far removed from medicine. This was unfortunate, as those connections are why I'd originally chosen to do my PhD. I realized that I really wanted to be closer to medicine and helping people in a specific way: in short, I wanted to move away from 'benchside' and move closer to 'bedside' without having to go earn another degree! In grad school I often found myself working in the lab, alone, into the wee hours. In my current work, I am still often working into the wee hours, but I am never really alone with the amount I get to communicate with my clients. I am talking on the phone, writing emails, going to meetings, listening to pitches, participating in panels, and otherwise directly communicating with people as part of the process of helping get medical devices to market. I feel connected. I feel like my impact is immediate and tangible for the quality of life of both patients and physicians.

While in grad school, I was interested in regulatory science, and took a class taught by Hank Greely at Stanford's center for Health Policy. It was an eye-opening class for me: we learned about the history of FDA and how they regulate drugs, biologics, and devices. I was hooked. I wanted to pick his brain and learn anything I could get my hands on. It was interesting, compelling, fun, and helped me realize what I really wanted to–and could–do. 

In short, I realized that I didn't want to stay in academia, regulatory was something I was very interested in, and I was motivated to finish my PhD so I could get a start on my next career path.

In 2009 I finished my PhD at Stanford, and fortuitously moved to Washington, DC due to my husband's job. I was looking for work and landed on an FDA posting that looked intriguing: a reviewer position in the the Office of Device Evaluation who could work on a side project dealing with the biocompatibility of device materials. I was thrilled to land the job! I loved the diversity of devices that I reviewed at the agency. Every day was different and every device posed exciting questions. My role at FDA truly merged my affinity for science with my love for medical technology. When my husband and I later moved back to California, that experience at FDA led to work on the 'other side', so to speak: regulatory consulting to help people navigate FDA. And long story short, AcKnowledge RS was born from this love of regulatory affairs.

For me there's no feeling quite like helping get a medical device to market, and in doing so, helping to make people's lives better. There is so much work to be done, and there's room for all of us who love doing it. It's an exciting and meaningful business to be in and we will continue to see growth in the years ahead with all of the innovative technology out there. In order to break into this field, my very unofficial advice based on my own experience is as follows.

First, check out your local and not-so-local resources. The Regulatory Affairs Professional Society (RAPS) is a great place to start. They offer education and training, networking, career resources, and more. In their own words:

"The Regulatory Affairs Professionals Society (RAPS) is the largest global organization of and for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics and nutritional products. Founded in 1976, RAPS helped establish the regulatory profession and continues to actively support the professional and lead the profession as a neutral, non-lobbying nonprofit organization. RAPS offers education and training, professional standards, publications, research, knowledge sharing, networking, career development opportunities and other valuable resources, including Regulatory Affairs Certification (RAC), the only post-academic professional credential to recognize regulatory excellence."

They're headquartered in Rockville, MD but have worldwide offices and local chapters.

They have also compiled this very helpful list of regulatory affairs degree and certificate programs that are available nationally and internationally.

Lots of cities have awesome regulatory affairs networks that help professionals meet people, get involved, and break into the field (RAPS does this too). For instance, in San Diego the San Diego Regulatory Affairs Network (SDRAN) offers opportunities for networking and mentorship, as well as internship programs and classes. In fact, I took their course on Canadian regulatory earlier this year! 

In their own words: "SDRAN is a nonprofit organization dedicated to educating and supporting our members through various educational and professional development venues including:

  • Monthly educational programs

  • RAC Study Groups to prepare for the US and EU exams are offered every summer  and include a reimbursement option for those who are not eligible for a company reimbursement.

  • Mentoring program to help promote the career growth and development of our members."

UCSD Extension also offers classes and certificate programs.

Speaking of education, there are other ways you can get involved via education even if not directly enrolled in these programs. In my last year of grad school I started taking classes that had to do with things like patent law and the history of FDA, which gave me a taste for something outside research science. In addition, I expect opportunities to continue to grow with technology. For instance, universities seem to be starting to focus more on medical devices in innovative ways. In some cases, students shadow physicians to get a view into their world, then begin creating things based on the unmet needs of the hospital. Pretty exciting stuff.

So, local and national resources? Check.

Education? Check.

Next: how do you get a regulatory job if didn't cut your teeth at FDA? What else: Networking.

Roll up your sleeves. Talk to people. Tell people what you're interested in and offer to help where you can. There may be small ways to network and learn in your current role that you may be missing out on.

I'd always recommend getting a job in an industry you're interested in, and volunteering your services to the regulatory folks at your company. Maybe you're already in biotech or at a med device company doing R&D, or something similar. If there's a regulatory team at your company, chances are your paths will cross at some point, whether you're in marketing or in the lab: regulatory permeates everything, and the team will have to work across the organization to help with a submission. That means there's an opportunity to get involved, learn, offer to help, and either shift over to that department or, with the added help of the resources outlined above, maybe move on to something else.

A final note on networking: Just do it! You never know where a conversation will lead. When I was starting out on my own, I relied on students, professors, friends, and anyone I knew that could help me learn. From hiring a QuickBooks teacher, to throwing together a website, or knowing someone who knew someone who could help introduce me to a potential a client - I couldn't afford to be afraid to let people know what I was doing.

That's my story. What's yours?