Regulatory Affairs Certification (RAC) Guide - Eligibility, Exams & Benefits

The Regulatory Affairs Certification (RAC) is the only post-academic credential for regulatory professionals in the healthcare product industry. Simply put, it is the gold stamp of approval that sets regulatory professionals apart as experts.

Who should consider earning regulatory affairs certification (RAC)? The short answer is anyone who currently works in regulatory affairs in an entry-level or leadership role. In general, careers in regulatory affairs are divided into two categories: regulatory affairs specialists and regulatory affairs managers.

While both positions require a minimum of a bachelor’s degree, regulatory affairs specialists earn average annual salaries of $71,690 (O*Net Online 2023) compared to regulatory affairs managers, who earn average annual salaries of $128,620 (O*Net Online 2023). And while RAC isn’t always a requirement, applicants can safely assume that having regulatory affairs certification can boost a regulatory professional’s chances of moving into leadership opportunities and earning higher salaries throughout their career.

Regulatory affairs professionals are tasked with reviewing data, writing reports and applications, and communicating with teams to ensure that the design, development, and marketing complies with legal regulations. As well, regulatory affairs personnel coordinate audits and inspections by regulatory groups. According to CareerOneStop (2023), an organization sponsored by the US Department of Labor, “regulatory affairs managers and compliance managers keep organizations and products on the right side of rules and requirements so that the public good is protected.”

The Regulatory Affairs Professional Society (RAPS) is the world’s largest global organization surrounding regulatory affairs in healthcare. RAPS offers two types of regulatory affairs certifications: RAC devices and RAC drugs.

• The RAC device exam is designed for medical devices and in vitro diagnostic products with three or more years of experience.
• The RAC drugs exam is suited for pharmaceutical and biotechnology regulatory professionals with three or more years of experience.

Both RAC exams require candidates to demonstrate knowledge of US FDA requirements, European regulations, and ISO guidelines and standards set forth by the World Health Organization (WHO).

While working towards the minimum three-year work experience requirement, regulatory affairs specialists are encouraged to join RAPS to take advantage of global networking opportunities. The organization is more than 30,000 members strong and offers one or two-year membership tiers ranging from $70 to $420 for individuals and teams. In addition to certification, since 1976, the Regulatory Affairs Professionals Society has advocated for industry standards and provided career development resources.

The mission of RAPS is to “Develop and sustain a competent global regulatory workforce that drives good regulatory practice and policy to advance public health.” The RAPS Online University offers continuing education opportunities through webcasts, virtual events, certificates, ebooks, virtual events, and more to support its professionals.

Read on to learn why earning a RAC credential is important, how it works, and what it takes to get it.

As global demand for regulatory professionals increases, those with the RAC put themselves at the top of the list for employment opportunities and into prime consideration for leadership responsibilities.

Approximately 7,000 people have been certified through the RAC; they are rising leaders in the regulatory arena. In 2021, RAC holders in North America reported earning 9 percent more than their non-credentialed peers. In addition, the organization holds annual conferences in North America and Europe. Finally, it offers its more than 30,000 members unparalleled in-person and online global networking and professional development opportunities for regulatory affairs professionals.

Furthermore, the RAC requires industry-specific knowledge and portable skill sets in critical thinking, adaptive reasoning, and collaboration. Thus, regulatory affairs certification can, in effect, boost the prestige of one’s resume, regardless of the sector or job role to which one applies.

To earn the RAC, one must pass a computer-based test designed for one of four geographic regions: the United States, Canada, the European Union, or Global. The exams are created by surveying veteran industry professionals on their scope of practice and specific roles and responsibilities.

Each test consists of 100 multiple choice questions that test-takers must answer in two hours at a sanctioned testing center. The questions fall into three general categories: recall, application, and analysis. The topics addressed include biologics and biotechnology, in vitro devices, medical devices, pharmaceuticals, and regulatory functions across the product lifecycle.

Regulatory professionals have to schedule enough time to review the exam’s content, assess their depth of experience, and implement a study plan to pass the test. Test-takers can earn a score ranging from 0 to 99, and a passing score is 75 or higher. The values are not necessarily correlated to the number of questions answered correctly or the percentage of questions answered correctly, but instead through a weighted statistical process to account for variations in question difficulty over the years. Therefore, most RAC exam-takers are forced to focus on doing the best they can and cross their fingers until the test is graded.

RAC examination scores are scored by Scantron off-site from the testing centers and are reviewed by a committee of statisticians to ensure accuracy and quality. Each exam is designed specifically for its geographical jurisdiction, and therefore those aspiring to earn a RAC credential should thoroughly acquaint themselves with local regulations according to their geographic region.

Fittingly, to comply with public health guidelines set forth by the Centers for Disease Control (CDC) and WHO, in 2020, RAPS began offering the RAC exam online from a home or office setting.

There are a few boxes to tick before taking the test. To be eligible to take the RAC exam, a candidate must be one of the following:

• Bachelor’s degree holder with three years of regulatory experience
• Master’s degree holder with two years of regulatory experience
• Doctoral degree holder with one year of regulatory experience

What qualifies as regulatory experience? Typically, regulatory expertise includes quality assurance, quality control, or clinical research related to the approval of healthcare products.

Since the tests are developed through extensive surveying and academic studies, the results can’t be offered free. Taking the test costs $495 for RAPS members and $625 for non-members.

Aspiring RAC candidates also must consider timing. Here are the application deadlines and testing windows for 2023:

Applications can be submitted through the RAC page.

Those behind the RAC want experienced and intelligent professionals to succeed. RAPS offers a wealth of resources to help applicants prepare and review the exam. They also provide test-takers a prep toolbox for their geographic region for an additional fee, which includes:

• An e-book of the US Regulatory Acronyms & Definitions
• A RAC practice exam
• An interactive study checklist
• An exam content cutline
• More than 25 hours of in-depth e-learning review material, including content from the Fundamentals of U.S. Regulatory Affairs
• Hands-on activities to help improve test-taking skills

Preparing for this exam is crucial since the pass rate is 40-50 percent. However, applicants should know that even if they don’t pass on their first attempt, they can retake the exam as soon as the next testing window opens. RAC exam results are available four to six weeks after the end of the testing cycle and are released directly to candidates and never via phone or fax.

Obtaining the RAC does not end with certification. Every three years, RAC holders are required to renew their certification by completing 36 RAC credits. Credits can be earned in several ways: continuing education, public speaking, professional writing, and involvement with professional organizations.

Current RAC holders can keep track of their continuing education credits and apply for recertification online through the RAPS membership site. The RAC recertification fee for RAPS members is $180 and $290 for non-members. In addition, RAPS offers a recertification late-fee option with a one-year grace period for those who let their credentials lapse. This renewal process ensures that only current experts hold the badge of RAC, thus maintaining the value of each individual’s certification.

Regulatory affairs professionals who hold both RAC devices and RAC drugs credentials need only submit one recertification application with 36 continuing education credits. As previously mentioned, RAPS Online University offers a wealth of resources available 24/7 to earn continuing education credits. In addition, the RAPS Executive Development Program, which partners with the Kellogg School of Management at Northwestern University, offers four-day in-person intensive experiences for regulatory affairs leaders and counts towards 12 continuing education credits.

Earning the RAC takes time, money, and effort, resulting in professional distinction and career advancement. Certificate holders can recoup the monetary costs through the boost in salary that comes with certification. In addition, the time spent studying for the test and earning renewal credits can boost one’s professional network and industry expertise.