April 23, 2024

by Ryan Connors

Is the Regulatory Affairs Certification right for you? An in-depth guide.

Thinking of pursuing your Regulatory Affairs Certification (RAC)? You’ve come to the right place. In this post, you will find information on eligibility requirements, exam details, and more for the leading credential in the healthcare product sector.

What is the RAC?

The RAC is a credential intended for individuals employed in industry, consultancies. regulatory agencies, and other settings involved with the regulation of healthcare products. Earning your RAC illustrates your regulatory proficiency, encourages ongoing professional development, and can even increase your earning potential.

There are two RAC credentials.* The RAC-Drugs credential, earned by passing the RAC-Drugs exam, is intended for professionals who work in pharmaceuticals. The RAC-Devices exam is for professionals who work in medical devices.

The RAC exams consist of 100 multiple-choice questions. Examinees must finish within two hours. The questions are in one of three formats:

Recall questions ask for specific information, typically about regulations and guidance that are important aspects of the regulatory process
Application questions require relating specific knowledge to a situation that may be encountered in the scope of practice of a regulatory professional
Analysis questions are small case studies or examples requiring the candidate to read and assemble information to identify and evaluate various solutions

Access the RAC-Devices Candidate Guide and the RAC-Drugs Candidate Guide for more information on RAC exam requirements, exam processes, and more.

Once earned, these credentials must be maintained. Credential holders commit to ongoing education and professional development through the recertification process every three years. Credential holders must earn 36 recertification credits every three years.

These credentials are different from the Regulatory Affairs Certificate Programs offered by RAPS Online University. The RAC is designed to assess and validate individual’s experience, knowledge, skills, and competencies required for successful job performance. The certificate programs from RAPS Online University, on the other hand, provide education to those looking to build their knowledge in regulatory affairs.

*Note: the RAC was previously offered in geographic designations. RAPS is not accepting new applications for the RAC-US, RAC-Europe, RAC-Canada, and RAC-Global, but individuals who earned the credentials previously may continue to recertify.

How do I know if the RAC is right for me?

There’s no one-size-fits-all answer to this question. But there are a few steps you can take to assess your fit and readiness for the RAC-Drugs or RAC-Devices exam.

1. Examine the RAC experience and education requirements

To be eligible for your RAC examination, you need to meet one of the following educational and professional experience eligibility requirement combinations:

Baccalaureate or equivalent first university degree and a minimum of three years of regulatory or regulatory-related work experience*

Master’s degree and a minimum of two years of regulatory or regulatory-related work experience
Doctorate degree and a minimum of one year of regulatory or regulatory-related work experience

* Regulatory-related experience may include quality assurance, quality control, clinical research related to the approval of health products or health product project management.

If you are looking to break into the regulatory field or have under three years of experience or equivalent, you are not eligible to take a RAC exam. There are other ways to invest in your career at this stage. For example, a Regulatory Affairs Certificate may be a better fit.

Certificate programs like the Regulatory Affairs Certificate are designed for individuals looking to build their knowledge. Credentials like the RAC are designed for individuals looking to validate their experience and differentiate themselves from their peers.

2. Know your candidate guide

There’s no better in-depth resource for the RAC. The Candidate Guides for the RAC-Drugs and RAC-Devices provide information on the entire process to ensure that each candidate knows the scope of their commitment. Pay attention to the content outline in the appendix to see what topics will be tested.

3. Make sure you have time to prepare

Every person’s RAC journey is different. Many RAC holders suggest six months of study time. This does not mean six months of around-the-clock studying (get out and see the sun!). But it does underscore one thing: do not underestimate the scope of this exam.

View this post on Instagram

A post shared by RAPS (@regulatoryprofessionals)

RAC exams are offered in three windows each year: spring, summer and autumn. You can browse the exam schedule here.

4. Talk to RAC holders

If you work on a large team, chances are you may already know someone who has their RAC. If not, consider browsing our RAC Spotlights. These testimonials offer advice from current RAC holders. You’ll see some of them referenced in this article.

Why should I get my RAC?

Regulatory affairs professionals in medical devices and pharmaceuticals have many reasons to consider getting their RAC credential. Here are five, based on interviews with RAC holders.

1. It adds to your credibility

Putting “RAC” next to your name demonstrates that you have a solid foundation of regulatory knowledge, as well as analytical and critical thinking skills.

“I remember the first time I added the 'RAC' to my signature line,” says Emily Nesbitt, RAC-US. “I was having a particularly difficult conversation about a regulatory matter, and I noticed that the entire tone of the email exchanged changed once I had added "RAC" to my signature line. It felt like the credential added a little extra confidence in my level of knowledge. People seemed to respect my advice more.”

She’s not alone in thinking this.

“It definitely demonstrates that you have achieved something,” says Manan Shah, RAC-US. “I’m in a client-facing role, so definitely when the client looks at me, it just adds a lot of value.”

2. It can help you get paid more

Another potential benefit of the RAC is higher pay. According to the RAPS 2022 Global Compensation and Scope of Practice Report, regulatory professionals with the credential, on average, earn 7.5% more than their peers without it. While it depends on the employer, hiring managers familiar with the RAC are often willing to pay an RAC holder more than a comparable professional without the credential.

3. It can help you get a better job

As an outward indication of regulatory knowledge that has clear value to employers and clients, the RAC can help credentialed professionals stand out to potential employers.

The RAC “really demonstrates a level of commitment to oneself and one’s career,” says Paul Swift, RAC-US. "As a hiring manager it’s definitely something I look for and something I’d encourage.”

Although it may not be the primary reason driving you to get the RAC, the process of studying for your exam can also be a benefit. Preparing for the exam will require you to learn new areas of regulation and reinforce your established expertise.

View this post on Instagram

A post shared by RAPS (@regulatoryprofessionals)

“I think the RAC credential has been instrumental in my professional development,” says Darshika Doshi, RAC-US, RAC-Drugs. “The rigorous exam preparation instilled in me the habit of retaining crucial facts and information. This has not only enhanced my day-to-day job performance, but also empowers me to think on the spot, and have that agility in addressing regulatory questions.”

4. It can help you stay current

To maintain the credential, RAC holders must recertify every three years by participating in continuing education and other professional activities. This process affords its own benefit. The continuing education requirement helps ensure RAC holders take the time to stay current with new regulations and developments.

“My RAC helps me so much in keeping up with the changing regulatory landscape,” Shah says. “If I want to navigate my client toward the right regulatory strategies, my RAC helps me because of the knowledge I got during my certification and in my recertification.”

Ready to sign up for your RAC exam? Here is how to apply.

How do I prepare for my RAC exam?

This link has more information on the domains covered on the RAC exams

Once you’ve considered the above, there’s only one thing left to do: start preparing.

“You have to devote yourself,” Paul Swift says. “Think about how you learn, how you learn best. 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 of the above.... Figure out how you work best, what your baseline knowledge is and build it from there.”

We have a whole separate article with tips from RAC holders, but we'll offer a few here. And remember: preparation for your RAC exam doesn’t have to wait until you register for your exam.

1. Block out some time — and stick to your schedule

Everyone studies a bit differently, so we won’t get into specific study tips here. Whether you’re planning on spending six months or four weeks on your exam prep, the most important thing is that you pick a plan and stick to it.

Whether that is regular three-hour long stints at the library or 15-minute study sessions during your lunch break, consistency is key.

2. Get some solid study materials

Once you’ve decided to take your RAC exam, it’s time to dive back into your candidate guide to make sure you know what’s on the exam as well as how and where to take it.

“It gives you a list of what the topics are so you can go through and say, okay, I know a good amount about this, but not this, so this is what I should study up on,” says Elizabeth Bereza, RAC-Devices.

RAPS offers free RAC prep checklists for each exam here, which can help you assess your knowledge. RAPS also offers RAC Prep Toolboxes and Bundles,* which include practice tests, books, e-learning courses and more. Whichever study strategy you choose, your tools will be crucial.

Many candidates benefit from taking the RAC practice exam to determine their gap areas and how best to allocate their study time.

“You should really do a full-court press if you can,” says Michelle Lott, RAC-US. “Especially if your company will support and fund those resources. Give it all you got and make it as easy as possible for yourself.”

3. Consider creating a study group

A study group can ensure that you’re not alone when you study, both figuratively and literally. Study group mates can help shoulder some of the burden and fill in knowledge gaps. Just remember: it’s always best to try to put in as much as you get out of a RAC study group. You don’t want to be the person who shows up and coasts off of everyone else’s notes.

And just because study groups work for some people doesn’t mean they’re necessarily the right fit for you.

“Everyone prepares for the exam differently, so evaluate what works best for you,” says Shalin Parikh, RAC-Devices. “For example, I’m not much into study groups. I just prepare myself, individually. But I know there are a lot of study groups out there and some people might like that approach.”

Feeling ready to get your RAC?

There’s a lot that goes into getting your RAC credential. We have summed up some of the topics here, but this article is intended as a starting point and not a comprehensive guide. Here are a few helpful links to help you continue your journey:

This article was initially published by Zac Brousseau in 2021. Some original content remains, while some has been updated.

Return to listing