How to prepare for the RAC exam: 9 tips to get your Regulatory Affairs Certification

Earning your Regulatory Affairs Certification (RAC) is a significant investment in your regulatory career. 

A RAC credential shows employers, clients, colleagues and others not only that you have the requisite regulatory knowledge, but that you are also committed to your profession. 

To get your RAC credential, you must pass one of two challenging RAC exams: the RAC-Drugs Exam, which confers the RAC-Drugs credential, or the RAC-Devices Exam, which confers the RAC-Devices credential. 

The average pass rate for these exams is between 40% and 50%. To pass, you will need to be well-prepared. We’ve gathered RAC exam study tips from RAC-credentialed professionals below to help you optimize your RAC exam study process. 

Ready to get your RAC? Here’s how to take the next step. 

How do I study for my RAC exam?

There’s no one-size-fits-all study plan that ensures you’ll ace your RAC exam. But these study tips can help.

Your RAC preparation can — and probably should — start before you register for your exam

Both RAC exams — RAC-Devices and RAC–Drugs — require that a professional has a minimum of three years of regulatory experience.

The exams test more than just knowledge. You also must demonstrate the analytical and critical thinking skills needed in real-world situations.

“The exam is not just about content mastery. You need to have experience to choose viable and practical solutions to the case studies presented,” says Mark Kramer, RAC, president of Regulatory Strategies Inc.

When it comes to being exam-ready, there simply is no substitute for experience. Still, even a seasoned regulatory expert will have to devote time to study and preparation.

The first step to developing your study plan is knowing exactly what is covered by the RAC exam you have chosen, as well as the exam format. This essential information can be found in the content outlines section of the RAC Candidate Guides. These are free, downloadable resources every exam-taker should have.

Access the RAC-Devices Candidate Guide and the RAC-Drugs Candidate Guide for more information on RAC exam requirements and exam processes. A study checklist, available for each exam here, can also help you track your progress during exam preparation.

Get to know the RAC Exam format

The RAC exams are computer-based and consist of 100 multiple choice questions. They must be completed within two hours. There are three types of questions on the exams: recall, application and analysis:

• Recall questions ask for specific information, typically about regulations and guidance that are important aspects of the regulatory process. These questions may relate to any stage of product development and may relate to regulations specific to certain product types. 

• Application questions require relating specific knowledge to a situation that may be encountered in the scope of practice of a regulatory professional. 

• Analysis questions may describe a small case or example requiring the candidate to read and assemble information in order to identify and evaluate various solutions. 

Learn more about preparing for the RAC exam here.

Get to know the RAC Exam content

Each RAC Candidate Guide contains a high-level overview of areas covered by that exam. The outlines are divided into four subject domains. Each domain is further divided into sub-topics and competency statements describing, in broad terms, typical responsibilities regulatory professionals would be expected to perform or oversee.

The outlines also indicate the percentage of exam questions to expect within each domain. All exams are updated annually, and questions refer to regulations in effect as of 31 December of the previous year.

Personalize your RAC exam preparation

How you prepare for your RAC exam depends on your own regulatory experience and knowledge.  

The scope of each exam is extensive. Exam content encompasses all aspects of healthcare product regulations, standards, and compliance over the entire product lifecycle. 

“Think about how you learn," says Paul Swift, RAC-US, Head of Regulatory and Clinical Affairs, Americas at Carl Zeiss Meditec. “For some people, it’s going through RAPS online courses. For others, it’s reading or practice exams, other folks it’s flash cards and study groups or some combination of all the above. Think about how you learn best. Devote the time for it. Put a few months into it, at least. Figure out how you work best, what your baseline knowledge is and build it from there."

There are likely to be some areas with which you have little direct experience, and you may have to devote more time getting up to speed on aspects outside your scope of work. Use the content outlines for your exam to help you identify the areas you need to focus on most.

Identify your RAC Exam study tools and resources

There are many resources available to help you prepare for your RAC exam.

• Free study checklists help you prepare your study plan and identify knowledge gaps
• Practice tests help you assess your exam readiness and help you familiarize yourself with the types of questions and content found on the exam
• Books in RAPS’ Fundamentals series give you comprehensive information and reference material
• Online courses help you fill in knowledge gaps
• Flashcards help you memorize acronyms, abbreviations, and definitions

Consider a RAC Exam study group

Study groups, typically held virtually these days, are another great resource for RAC candidates, and many who have earned the credential participated in one as part of their preparations. 

Joining a study group can help you better understand concepts that were outside your core expertise. Study groups can also help boost your motivation. Having people other than yourself to whom you are accountable can help keep you on track.

Connect with other exam takers through the RAC Prep Community on RAPS’ Regulatory Exchange. RAPS chapters and local networking groups may also offer study groups. Sometimes, study groups are started by a group of employees at the same company — usually at larger companies with sizeable regulatory teams.

Seek the wisdom of experience

No one knows better how to successfully prepare for an RAC exam than those who have done it and passed the exam. If you know anyone who recently has earned the RAC, ask them about their preparation, including what they found most helpful and what they might have done differently with the benefit of hindsight. 

You’re sure to hear different tips or pitfalls from different people. And remember that something helpful to others may not work for you. You will have to judge how the methods used by others fit with your learning style, schedule, etc.

Browse our interviews with RAC holders here.

Invest the time

No matter how much experience you have or what resources or methods you use to prepare for the RAC exam, there is no getting around the fact it takes time to study. 

This may be one of greatest challenges for busy regulatory professionals, but the more time you can devote to focused preparation, the better you are likely to do on the exam. Although this simple fact is straightforward, acting on it takes dedication. But isn’t your dedication to regulatory affairs one of the big reasons why you are pursuing the RAC credential in the first place? 

Ready to take the next step in your RAC journey? 

See RAC holder stories, eligibility requirements, study materials and more here.

This article was originally published in 2018. It has been updated.