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This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Regulatory Affairs Specialist, Boston Scientific
RAC holder since 2021
I ended up in regulatory by chance as I was searching for jobs out of university. As an English major, I was searching for career paths that were writing based. When I first joined the Boston Scientific regulatory team, I wasn't sure what I was getting into, but the more I learned, the more I began to enjoy it.
A typical day includes assessing proposed changes from our engineers, compiling documents and submission content for international registrations, and communicating with colleagues around the world.
I was helping with the development of a strategy for an FDA submission and something I had read in the textbook came to mind. While we were not able to apply that approach to the situation, it was a clear connection between studying for the RAC and my job.
Talk to someone already working in the department to get a good idea of what the job entails. Information on the internet doesn't explain things very well for those unfamiliar with the career path.