What is the RAC?

Regulatory Affairs Certification (RAC) is the leading post-academic professional credential for regulatory professionals in the healthcare product sector. It is intended for individuals employed in regulatory agencies, industry, consultancies and other settings involved with the regulation of healthcare products. Regulatory Affairs Certification tests expertise in two sectors, pharmaceuticals and medical devices, and candidates may choose whether to take the RAC Drugs exam or the RAC Devices exam. All candidates who pass an RAC exam will be equally recognized by the RAC program and will be eligible to put ‘RAC’ after their name.

RAC Examination Overview

  • There are two different RAC exams: RAC Drugs and RAC Devices.
  • Each examination is based on a survey of the scope of practice and specific roles and responsibilities of regulatory professionals in the workplace with at least three years of regulatory experience. Each examination is reviewed and revised annually, and content is updated for the Summer cycle.
  • Exam content for RAC exams is based on regulations and guidelines in effect on December 31 of the year prior. So, exams taken in Summer 2022 will be based on regulations ‘on the books’ on December 31, 2021. For the RAC Devices exam, this includes both MDD and MDR.
  • Each examination consists of 100 multiple choice questions to be answered in a two-hour period. Additional time may be allowed for candidates who have requested and received special accommodations. To request special accommodations, please complete the appropriate form in the Appendix of the RAC Candidate Guide
  • The RAC exams are computer-based and administered only at testing centers selected and confirmed by the testing vendor. NOTE: RAC examinations will not be offered at facilities that are not pre-selected and qualified for security measures.
  • There are three question formats which may be used in the RAC exams:
Recall question asked 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 for product types.
Application questions require relating specific knowledge to a situation that may be ecountered in the scope of practice of a regulatory professional.
Analysis questions may be described as a small case or example requiring the candidate to read an assemble information in order to identify and evaluate various solutions.


Knowledge Required and Regulatory Basis

RAC Benefits for You

  • Illustrates your regulatory proficiency
  • Highlights your professional and personal accomplishments in regulatory affairs
  • Encourages continuous career development through credential maintenance
  • Promotes career longevity and advancement through continued skill development
  • Secures greater earning potential—RAC holders earn 7.5% more than those without the credential (RAPS 2022 Scope of Practice Survey)

RAC Benefits for Your Employer

  • Validates your employee’s professional competence in the regulatory field
  • Promotes ongoing professional development through credential maintenance
  • Encourage development of a more productive and highly trained workforce

Key Terms

  • RAC—Regulatory Affairs Certification
  • RACB—Regulatory Affairs Certification Board
  • RAPS—Regulatory Affairs Professionals Society
  • Candidate(s)—an individual who is interested in taking, or who has applied to take, an RAC examination or who has taken an examination but has not yet been notified of the result
  • Certificant—an individual who passes one or more RAC examinations and actively maintains their status
  • RAC—related individuals—members of the RACB, examination committees, staff supporting the RAC Program, vendors and consultants
  • RAC testing vendor—contracted organization providing psychometric and testing support services for the RAC program

Learn about the application process >>

How the RAC is Developed

The Regulatory Affairs Certification Board (RACB) oversees the development of the RAC examinations. Each examination is developed by an examination committee comprised of practicing regulatory experts knowledgeable about the relevant regulations for the region.

The RAC examinations are based on job analysis studies undertaken by the RAC program. These studies are guided by experts in testing and measurement. The job analysis studies are completed before an examination is created and repeated as needed to determine whether there are changes in the role and scope of practice of regulatory professionals that would require adjustment of the examination content. The job analysis study is used to develop the content outline for each examination and determine the number and type of questions to be included in each content area.

Questions on the examinations are updated every year to reflect current regulations, guidelines and practice.