Alumna Profile

Sudipta Chakrabarti, 2012 Graduate

Regulatory Compliance Specialist, FUJIFILM SonoSite

Sudipta Chakrabarti completed the Master of Science in Biomedical Regulatory Affairs at the University of Washington in 2012 and now works as a regulatory compliance specialist at FUJIFILM SonoSite, a company that creates bedside and point-of-care ultrasound imaging. Having worked as a pharmacist in India, Sudipta was familiar with the drug industry, but after moving to the United States she decided to switch career paths. In this interview, Sudipta explains how the program helped her pursue and succeed in her new career.

Can you talk a bit about your educational and professional background?
I have a pharmacy degree from India and worked as an intern in a drug company as an undergraduate. After moving to the United States I wanted to build a new career related to my health care background, something that would be challenging and interesting. I first entered the UW Certificate in Clinical Trials, and I really liked the program, so I decided to apply for the master's program [in Biomedical Regulatory Affairs].

What do you do in your current job?
I work as a regulatory compliance specialist at FUJIFILM SonoSite. I work with two groups there, compliance engineering and regulatory compliance. For the compliance engineering group, I assist in safety testing, help in maintaining our internal compliance documents and assist in submissions to the Canadian Standards Associations in order to obtain CSA marking on our products. A CSA registered mark shows that our product has been independently tested and certified in order to meet recognized standards for safety and performance. For the regulatory compliance group, I handle complaints about our products.

How did the master's program in biomedical regulatory affairs help you develop your new career?
Because I was a pharmacist before, my specialty was more on drugs than medical devices. But during my master's program, I took classes on medical devices. I found I enjoyed the engineering part of devices, although I'm not an engineer. I also love testing devices, the labs and the regulations for devices. It's really fun for me. I decided I wanted to work in the device world.

That's a nice thing that the program offers, you can do all your work on devices, drugs or biologics. There were a few classes where all subjects were covered, but mostly I could select projects related to the device industry.

What was your practicum experience like?
The practicum project is a good thing because I could work for a device company for a few months. I literally could get a better feel for how it would be to work in that field.

My practicum was at Philips Healthcare. My job was to come up with a chart showing the similarities and differences between the Summary Technical Documentation guidance documents for four countries – the United States, Canada, Japan and Australia – and to compare those requirements to the original guidance document for STED submission developed by the Global Harmonization Task Force.

How did the program help you discover job opportunities?
We had guest lecturers who work in both drug and device companies, and we were able to make those contacts and network with them. Some students got projects through meeting these guest lecturers and eventually landed a job in the same company because of their project experience there.

For me it was different. I did a project in a different company from where I was eventually hired. But getting to know the people in the program was important, since they helped me discover companies to apply to. There are a lot of companies you don't even know exist.

What were the most helpful aspects of the program for you?
The regulatory classes helped prepare me for the regulatory affairs part of my current job. We had classes that gave us an overall idea about devices, drugs and biologics and the FDA and how it works. Since I was totally new to this area, that information was really helpful, as were classes about international regulatory affairs.

The writing classes were also really helpful for me because English is not my first language. In the regulatory industry, there's a lot of writing involved. So I can definitely say those classes helped me a lot, and I use what I learned every day.

What did you enjoy most about the program?
I really liked that it was a cohort-based program. Since we all took classes together, we were able to make friends and network. Even now, we help each other find jobs.

Do you have any advice for people considering this program?
For people like me who are new to this field, I would say to be open minded when they're joining the program. Because this program offers three different areas – drugs, devices and biologics – students can focus on their particular interests. By the time they finish the first or second quarter, they'll have a better idea of what area they want to choose. I'd suggest that they choose a practicum project in the area they want to eventually work in, so they can get experience in that area.

Once you graduate you can work in regulatory affairs or clinical trials for a variety of different companies. In short, the program gives students just a huge range of opportunities.