MITS Training for the Regulatory Affairs Certification (RAC®) Exam

Why do you need to certify?

The fundamental purpose of any professional certification program is to offer an independent, dependable assessment of the knowledge and skills comprehension required for having an edge in performing a professional role. This assessment, like any other, is typically accomplished by the successful completion of the given examination.

What is a Regulatory Affairs Certification (RAC)?

The Regulatory Affairs Certification is a professional credential that means commitment to excellence, pursuit of knowledge and career improvement. If the individual has been successful after taking the RAC examination, it proves that he or she has met the required knowledge of the appropriate regulations and the ability to think wisely regarding all of the regulatory issues and difficulties that occur on the entire duration of a healthcare product lifecycle. RAC-licensed professionals are among today’s rising leaders in the regulatory profession. As of now, there are more than 6,000 professionals who have gained the RAC, while some are holding multiple credentials.

What is the value of the RAC in today’s industry?

The RAC is considered as the only accreditation for the regulatory professional in the healthcare product industry. The RAC is applicable to employers, customers and associates that a regulatory professional has the important knowledge, skills, decision-making abilities and commitment to improve professional knowledge and capabilities. In today’s era, RAC-credentialed professionals are well positioned to be an organization’s proactive team members and contributors in every work environment, as the demand for adequate regulatory professionals increases globally. Acknowledgement of the RAC has steadily grown across the globe and RAC-credentialed professionals gain increasing work salaries than those who do not hold the said credential.

What kind of examination is offered to get a certificate?

The Regulatory Affairs Certification Board (RACB) upholds the development of the RAC examinations. Each examination is established by an examination committee which consists of practicing regulatory experts that are knowledgeable regarding the applicable regulations for the region.

The examination content outlines and the RAC examinations are based accordingly on job analysis (role description) studies covered by the RAC program. These studies are assisted by experts in testing and measurement, and these are completed before an examination is constructed and duplicated as needed so as to know whether there are innovations in the role and scope of practice of regulatory professionals that would demand adaptation of the examination content.

Such examination is offered twice a year, in March and in September.

How can you apply for the examination?

Prior to taking the said examination, there are several eligibility requirements that have to be met accordingly. If you wish to apply, you need to review your eligibility requirements carefully before starting the application process. You should meet one of the following educational and professional experience requirement combinations:

  • Baccalaureate or equivalent degree and a minimum of three (3) years of regulatory or regulatory-related work experience
  • Master’s degree and a minimum of two (2) years of regulatory or regulatory-related work experience
  • Doctorate degree and a minimum of one (1) year of regulatory or regulatory-related work experience

Once you have secured that you’ve met any of the requirements above, thus you’re ready to begin the application procedure. To begin, you may apply for the RAC® Exam online or submit the printable application form that you can obtain from the RAPS website. You will be guided accordingly on your next steps as soon as you’ve completed the application process.

How can I maintain my credential?

To any regulatory professional, continuous learning, knowledge improvement and professional development are essential to maintain the integrity of your credentials. Once certified, maintaining your RAC can be done through continued learning and experience in professional activities. You are required to renew your RAC every three (3) years by gaining 36 RAC recertification credits. To individuals who possess more than one RAC designation are only required to submit a single recertification application with a total of 36 credits.

The recertification cycle is according on the initial RAC certification and the incorporated recertification cycle.


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