The Regulatory Affairs Certification, or RAC, is a voluntary professional credential from RAPS. It shows you know how health products are regulated, and it suits people who want to work in regulatory affairs for drugs or medical devices.
Official website ↗The RAC is an international credential that people earn and use in Canada. It is not required by law or by any employer standard. Many people still choose it because it gives a clear, recognized sign of regulatory knowledge.
It is useful for regulatory affairs specialists, pharmaceutical regulatory affairs specialists, pharmaceutical scientists, medical device researchers and biomedical engineers. It can also help medical regulatory lawyers who advise companies on product approvals. In Canada, much of this work involves preparing submissions and dealing with Health Canada, the federal regulator for drugs and medical devices.
Holding the RAC can help you stand out when you apply for jobs or move into a more senior role. It can also help you change careers, for example from lab science or engineering into regulatory work. Since it is voluntary, you can earn it at whatever point in your career suits you.
The RAC exam is a written, multiple-choice test. It checks that you understand regulatory rules, submissions and product lifecycle topics. Expect questions that ask you to apply knowledge to realistic work situations, not just recall facts. Because the exam is international, you should also study how Canadian rules fit with what is taught.
The RAC must be renewed to stay current. You do this by completing continuing education activities that RAPS recognizes, and by paying a renewal fee. Keep a simple record of your learning as you go, so renewal is easy when the time comes.