Regulatory Focus™ > News Articles > Why Get Regulatory Affairs Certification? Ask Those Who Have It

Why Get Regulatory Affairs Certification? Ask Those Who Have It

Posted 15 July 2013 | By Zachary Brousseau

As a regulatory professional, you may be considering Regulatory Affairs Certification (RAC) as a way to distinguish yourself, demonstrate your regulatory knowledge and skills, advance your career or even as a tool to help you expand and sharpen your grasp of regulatory issues and critical thinking skills. After all, the RAC is the only post-academic professional certification specifically for healthcare product regulatory professionals.

But what do those who have the credential have to say about it? RAPS decided to ask some RAC-certified professionals about their experiences in attaining and having the RAC.

Regulatory Affairs Certification

First introduced in 1991, the RAC designation has garnered a reputation as an important credential during its relatively short existence. To date, about 7,000 professionals have earned the RAC credential. It is "most definitely essential to the serious regulatory professional," said Peter Takes, vice president, regulatory and clinical affairs and quality systems for Kypha Inc, St. Louis.

The credential is earned by passing one of four exams. Three of the exams cover the regulations of the US, EU and Canada, respectively. The fourth, the RAC Global exam, covers knowledge of regulatory functions and global standards commonly used in global harmonization or alignment initiatives by regulatory authorities around the world. All four exams are developed based upon the actual work of regulatory professionals in the field.

The RAC establishes standards for the regulatory profession and identifies individuals who meet those standards. This allows RAC holders to validate their regulatory knowledge and assure supervisors, colleagues, clients and agency officials of their competence and professional status.

"Not only does it provide a benchmark for achievement, but it also projects the individual in a highly respected manner," said Bob Schiffman, principal consultant, Medical Device Industry Specialist LLC, in Meriden, CT.

It can even help drive business. "I receive more inquiries based on the fact I am an RAC," commented John Beasley, founder and senior consultant at MedTech Review LLC in Minnetonka, MN.

RAC-credentialed professionals are among the most respected in the regulatory field, and the credential can help both seasoned professionals and rising leaders differentiate themselves.

"The RAC allowed me to stand out from those colleagues who were not certified," said Ashlea Ricci, senior regulatory affairs specialist with Teleflex Medical in Triangle Park, NC. "My manager at the time had not sat for her RAC, and was greatly impressed that I was able to accomplish this goal on my own time, outside of work. I believe that the RAC shows my dedication to the profession and sets me apart from others who have not taken the time to commit to the exam."

The RAC has helped regulatory professionals around the world advance their careers. "It is definitely a way to accelerate your value and employability in the market," said Luciano Ferreira, regulatory intelligence manager at GE Healthcare in São Paulo, Brazil.

"As senior management, I look first at candidates holding a RAC to fill open regulatory positions," said Takes. "All other elements equal, the candidate with the RAC will secure the job."

In addition to being looked upon more favorably by many managers and employers, regulatory professionals with the RAC earn nearly 10% more on average than their peers at the same professional level who do not have the RAC, according to RAPS' 2012 Scope of Practice & Compensation Report for the Regulatory Profession.

In addition to validating regulatory knowledge and helping professionals better position themselves in their careers and market their skills, the RAC has other advantages. RACs must recertify every three years by participating in educational and professional activities. This requirement benefits the certified individuals, their employers, the regulatory profession and the overall healthcare product sector by encouraging professional growth and continued learning.

"The continuing education requirement helps ensure that we take the time to step back from our daily activities and stay current with what is happening in the regulatory landscape," said Paul Swift, regulatory affairs specialist with BD Diagnostics in Sparks, MD.

Some with the RAC report that it has helped prepare them to take on new job responsibilities beyond their core expertise. "It has helped me become more confident about working in areas I have not worked in before as I learned the basics while studying for the RAC," said Cassie Vitolo, regulatory CMC manager at Merial, a Sanofi Company, in Atlanta.

"I think the exam is worth the investment, and allows you to expand your knowledge by looking outside of your product scope," said Darin Oppenheimer, associate director of regulatory affairs for Baxter Healthcare in Deerfield, IL.

There are many reasons to pursue RAC certification, from career advancement to challenging yourself to solidifying your credentials as a regulatory expert. Ultimately, the decision is a personal one, but several current professionals with the RAC offered advice for those thinking about seeking certification.

"For those who are considering getting certified, I would recommend that they not delay," said Ricci. "More and more people are obtaining their certification, and I believe that RAC credentials will continue to grow in importance over the next few years. Taking the RAC exam now would allow professionals, especially young professionals, to get ahead of the curve."

For more information about RAC or to register for the exam, visit

This is an updated version of an article originally published in Regulatory Focus, July 2011.

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