Biomedical Engineer Discovers Regulatory Affairs Network at UCSC Extension


- Leena Kadakia

Term : September, 2014
Department : Biosciences
Program : Regulatory Affairs

As an engineer, Leena Kadakia often worked alongside regulatory affairs professionals, translating technical concepts. Though her background in chemical and biomedical engineering qualified her for a lot of exciting opportunities, her interests soon shifted into the regulatory realm. Kadakia realized that she’d need a better grasp of FDA regulation submissions process in order to be considered for jobs with a regulatory focus. That’s when she discovered UCSC Extension’s Regulatory Affairs certificate program—and met instructors who helped open new doors for her.

What skills did you learn in class that you now apply at work?

“Regulation of Medical Devices and Diagnostics” gives you a great foundation and basis. The instructors do a superb job of giving real-world examples and explaining FDA regulations. “Regulatory Submissions: Devices and Diagnostics” is where you apply everything; the instructor doesn’t just test facts. He tests your understanding of multiple courses you’ve taken, and how you apply it to a submission. Essentially, you learn what you’d have to do if you go in a real-world work environment.

What were some of the benefits of pursuing the certificate?

The course work was fantastic; it helped me prepare for the RAC exam, which I passed in November 2013. My instructors recognized my potential, and they have been instrumental in helping me find new positions. I wasn’t expecting to find instructors who would be so willing to help me. Now I consult in regulatory affairs for a few different companies.

What advice do you have for aspiring regulatory affairs professionals?

People don’t realize how technical regulatory affairs are these days. You often need an engineering or biomedical background in order to fill certain positions.  What people need are entry-level jobs or internships where they can get practical experience and see how to apply their knowledge. If you’re interested in regulatory affairs, you really need to take “Regulatory Submissions: Devices and Diagnostics” to see what you are getting into.

Kadakia completed the Regulatory Affairs certificate in summer 2013.

Visit our Regulatory Affairs program page to learn more about Extension’s unique offerings. Browse upcoming Regulatory Affairs courses.

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