- Shilpa Mydur
When Shilpa Mydur relocated to Silicon Valley from Ohio, she had already completed an M.S. in nutritional science and was working as a product development scientist in an established medical nutritionals company. She was interested in translating her expertise to the medical device industry—though she didn’t know where to start. A friend referred her to UCSC Extension, where she enrolled in a “Regulation of Medical Devices and Diagnostics,” in an effort to “gauge the flavor of regulatory affairs.” After the first class, she was hooked. By the time she completed the certificate in Regulatory Affairs, Mydur had the knowledge and experience to land her first position as a regulatory affairs professional in a Silicon Valley startup.
What inspired you to pursue the certificate?
I was absolutely floored by my first class. The teacher was so great, and gave such good life examples. I got to see what a 510K submission is all about. The knowledge I learned in “Regulation of Medical Devices and Diagnostics” helped me with my actual job; I learned how to organize and format an FDA submission and propose arguments in a very convincing way.
What kind of practical knowledge did you learn?
“Drug Development Process” did a great job of exposing us to the nuances of the drug world, which was helpful to me because I had no experience on the drug side of things. In “Quality Systems for Medical Devices,” we had to present a real-life example of when a company had failed to follow the FDA submissions process. The courses were a way to keep ourselves up-to-date; they give you tips on where to go and what to look for when you are navigating regulatory affairs, not just in the U.S., but around the world.
What skills do regulatory affairs professionals need?
Because regulatory affairs is deeply embedded in science, having a good scientific background is always a plus. You have to have the aptitude for learning scientific technology. I cannot emphasize enough the importance of networking—having a forum like UCSC Extension is great for that. Where else can you meet so many individuals of different industries and learn together? Taking a class helps to expand your own horizons and stay connected. I found my current position after completing Extension’s program; it definitely opened the door for me.