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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 Manager at 3M
RAC holder since 2015
I had previously worked in the lab in product development and in quality assurance. I liked the idea of working in regulatory because of the breadth of connections across many areas—allowing me to interact with lab, quality, marketing, business, legal and other functions.
I like that most days are unique. On any given day, I might be working on compliance, business growth, regulatory intelligence, international registrations, learning and development or any sort of combination. It’s never dull!
The feeling of getting my first 510(k) clearance letter and doing victory laps through the office!
I became certified in 2015 with my first RAC (US), back when the exams were regionally based. I followed the next year with my RAC (Global) certificate. Preparing for both exams really helped build my knowledge and confidence in the subject matter. My company encourages but does not require people to be certified and pays for the training and exam.
I bought the books/materials associated with the exam and read them. I took multiple practice exams, which was the most helpful in preparing to understand the way the questions would be asked and what level of detail I might expect.
Try to do informational interviews with peers and managers in the RA areas to learn more about what the job entails. Then, start with some introductory classes and learn more about the general topics. Starting with one regulatory area (EU, US, Canada, etc.) may be easier than trying to understand the global framework from the start.