What is the RAC?
The 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.
There are two RAC designations. There is one for Pharmaceuticals (RAC-Drugs) and one for Medical Devices (RAC-Devices). Candidates may take one exam or both exams. All candidates who pass an RAC exam will be equally recognized by the RAC program and will be eligible to put RAC-Drugs or RAC-Devices after their names.
RAC Exam Overview
- There are two RAC exams and designations: RAC-Drugs and RAC-Devices.
- Each exam 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 exam is revised annually.
- The RAC-Devices exam includes both MDD (Medical Devices) and MDR (Medical Device Regulations) content.
- Exams are in English.
- Each exam consists of 100 multiple choice questions to be answered in a two-hour period. Additional time may be allowed for candidates who have been approved for special accommodation.
- The exams are computer-based and proctored. They are administered at select testing centers and online by a third-party testing vendor.
- There are three question formats:
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Recall Recall questions ask 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 regulations specific to product types. Application Application questions require relating specific knowledge to a situation that may be encountered in the scope of practice of a regulatory professional. Analysis Analysis questions may be described as a small case or example requiring the candidate to read and assemble information in order to identify and evaluate various solutions. |
Full details can be found in the Candidate Guides for RAC-Drugs and RAC-Devices.
RAC Benefits for You
- Illustrates your regulatory proficiency
- Highlights your professional and personal accomplishments in regulatory affairs
- Encourages ongoing professional development through recertification
- Promotes career longevity and advancement through ongoing skill development
- Secures greater earning potential—RAC holders earn 7.5% more than those without the RAC (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 recertification
- Encourage development of a more productive and highly trained workforce
- Serves as a retention tool for valued employees
Learn about the application process >>
RAC Oversight and Development
The Regulatory Affairs Certification Board (RACB) oversees the RAC program. Each exam is developed by an exam committee comprised of practicing regulatory experts who are knowledgeable about the relevant regulations.
RAC exams are based on job analysis studies. These studies are guided by experts in testing and measurement. The job analysis studies are completed before an exam is created and repeated as needed to determine whether there are changes in the role and scope of professional practice that would require adjustment of the exam content. The job analysis study is used to develop the content outline for each exam and determine the number and type of questions to be included for each domain. Questions on the exams are updated annually to reflect current regulations, guidelines, and practice.