Get Recognized For Your Expertise in Regulatory Affairs
Earn the leading credential for regulatory professionals in the healthcare product sector.
Earning the Regulatory Affairs Certification (RAC) demonstrates your proficiency in regulatory affairs and distinguishes you from your peers, positioning you for career advancement and success. The RAC exams test critical thinking and analysis as well as regulatory expertise in the applicant’s designated healthcare product sector, either pharmaceuticals or medical devices.
Get Recognized For Your Expertise in Regulatory Affairs
Earn the leading credential for regulatory professionals in the healthcare product sector. Earn your RAC.
Earning the Regulatory Affairs Credential (RAC) demonstrates your proficiency in regulatory affairs and distinguishes you from your peers, positioning you for career advancement and success. The RAC exam tests critical thinking and analysis as well as regulatory expertise in the applicant’s designated healthcare product sector, either pharmaceuticals or medical devices.
What is the RAC
(Regulatory Affairs Certification)
Is it worth it? Who is it for? What do the exams test?
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 a RAC exam will be equally recognized by the RAC program and will be eligible to put ‘RAC’ after their name.
What is the RAC
(Regulatory Affairs Certification)
Is it worth it? Who is it for? What do the exams test?
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 spring exam cycle.
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.
RAC exams may be taken in-person at an approved testing site or taken from the comfort of your home or office using Live Online Proctoring.
There are three question formats used on the RAC exams:
Recall
Recall question 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 may relate to regulations specific for product types.
Application
Application questions require relating specific knowledge
to a situation that may be ecountered 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.
RAC Examination Overview
Knowledge Required and Regulatory Basis
RAC DEVICES
- Knowledge of the full product development and lifecycle requirements for medical devices, and IVDs.
- Knowledge of US FDA requirements (30%); European regulations and guidance from the European Commission and competent authorities (30%); and globally applicable regulatory practices* (40%). (*IMDRF, WHO and ISO guidelines and standards).
- Critical thinking and analytical skills.
RAC dRUGS
Knowledge Required and Regulatory Basis
How does the RAC benefit you and why do employers love it?
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 an average of 7.5% more than those without the credential*)
- 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 an average of 18% more than those without the credential*)
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
an average of 18% more than those without
the credential*)
How To Prepare For The RAC Exam
Review the examination content outline found in the candidate guide. Each content outline contains the content domains, task statements and exam weighting.
Assess the scope and depth of your knowledge and experience. Use the study checklist to evaluate your areas of strength and weakness. This will help focus your study on the areas you need most.
Build and implement your plan. Allow sufficient time to build your knowledge base in areas where you have limited experience and to expand your knowledge in areas more familiar to you. Use reference materials to supplement
your knowledge.
How To Prepare For The RAC Exam
Here are some things to consider:
Here are some things to consider:
Hear what leaders around the globe say about RAC
Hear what leaders around the globe say about RAC
Frequently Asked Questions
Why is the RAC program offering online testing now?
With the current COVID-19 pandemic, testing centers and candidates have seen restrictions on travel and opening availability, making exams very difficult to schedule. To allow candidates more flexibility the RAC Board has agreed to allow candidates the option to take the exam from their own laptop to get around these current restrictions. Candidates can choose to take the exam online with live online proctoring or at a testing center (subject to availability).
Are Canada specific questions still still on the RAC?
No. When the RAC Board designed the RAC Drugs and RAC devices they wanted to give candidate the challenge of understanding international regulations but felt that if questions were pulled from too broad a field it would make the exams too difficult for candidates to study for, and beyond the likely need of most regulatory professionals with 3-5 years of experience. As such the scope of the exams was limited to US, EU and a handful of global bodies that are considered universally applicable. Questions regarding specific countries outside the jurisdictions noted above are not part of the RAC exam.
Which exam should I take?
This is a decision that each individual must make for themselves. However, candidates may wish to consider where they see their future career heading, and how their prior experience may help them in passing
the exam.
How can I prepare for the RAC exams?
Preparation materials have been created by RAPS for the new exams. This includes practice exams, toolboxes, books, content outlines, checklists and more. For more details please see here.
Note: RAPS does not state or imply that RAC preparation material provided by RAPS is the best or only
means for preparing adequately for the RAC examination. No advantage is given to candidates who participate in preparation material provided by RAPS, over candidates who choose to prepare using any
other material or method. The use and purchase of preparation courses and materials is optional. RAPS and the RAC program does not state or imply that these education or training programs are the only or preferred route to certification.
Whare are the eligibility requirements for the new product based RAC credentials?
The RAC credential eligibility requirements remain unchanged. As with all eligibility requirements for the RAC, any changes will need to be approved by the RAC Board. The questions in all RAC exams will be of the same level (reflecting 3-5 years of experience in the profession).
Frequently Asked Questions
Demonstrate your mastery of regulatory affairs by earning your RAC. Get started today!
Regulatory Affairs Professionals Society (RAPS)
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Rockville, MD 20852
P +1 301 770 2920 | F +1 301 841 7956
Email: raps@raps.org
© 2024 Regulatory Affairs Professionals Society
- Knowledge of the full product development and lifecycle for pharmaceutical, and medicinal and related products, APIs, biologics, and biotechnology products.
- Knowledge of US FDA requirements (30%); European regulations and guidance from the European Commission, EMA, and competent authorities (30%); and globally applicable regulatory practices* (40%). (*ICH and WHO guidelines and standards).
- Critical thinking and analytical skills.
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 Spring exam cycle.
Exam content is based on regulations and guidelines in effect on December 31 of the year prior. So, exams taken in 2020 will be based on regulations ‘on the books on December 31, 2019. 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.
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.
RAC exams may be taken in-person at an approved testing site or taken from the comfort of your home or office using Live Online Proctoring.
There are three question formats used in the RAC exams:
- Knowledge of the full product development and lifecycle requirements for medical devices, and IVDs.
- Knowledge of US FDA requirements (30%); European regulations and guidance from the European Commission and competent authorities (30%); and globally applicable regulatory practices* (40%). (*IMDRF, WHO and ISO guidelines and standards).
- Critical thinking and analytical skills.
- Knowledge of the full product development and lifecycle for pharmaceutical, and medicinal and related products, APIs, biologics, and biotechnology products.
- Knowledge of US FDA requirements (30%); European regulations and guidance from the European Commission, EMA, and competent authorities (30%); and globally applicable regulatory practices* (40%). (*ICH and WHO guidelines
and standards). - Critical thinking and analytical skills.
RAC Benefits for Your Employer
Validates your employee’s professional competence in the regulatory field
Promotes ongoing professional development through
recertification
Encourages development of a more productive and highly
trained workforce
Serves as a retention tool for valued employees
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
How does the RAC benefit you and why do employers love it.
Where should we send free RAC related materials?
We won’t spam you!
Where should we send free RAC related materials?
We won’t spam you!
Need help convincing your boss?
To help make your case, we’ve put together a customizable letter template to justify the investment in your professional development.
Note: RAPS does not state or imply that RAC preparation material provided by RAPS is the best or only means for preparing adequately for the RAC examination. No advantage is given to candidates who participate in preparation material provided by RAPS, over candidates who choose to prepare using any other material or method. The use and purchase of preparation courses and materials is optional. RAPS and the RAC program does not state or imply that these education or training programs are the only or preferred route to certification.
To be eligible for the RAC examination you need to meet one of the following educational and professional experience requirement combinations:
- Baccalaureate or equivalent first university degree and a minimum of three years of regulatory or regulatory-related work experience.*
- Master’s degree and a minimum of two years of regulatory or regulatory-related work experience.*
- Doctorate degree and a minimum of one year of regulatory or regulatory-related work experience.*
Frequently Asked Questions
Demonstrate your mastery of regulatory affairs by earning your RAC. Get started today
I was having a particular difficult conversation about a regulatory matter, and I noticed that the entire tone of the email exchanged changed once I had added “RAC” to my signature line.
Emily Nesbitt
Associate Director, Regulatory Affairs
Ethicon, J&J
Montgomery, OH (USA)
RAC holder since 2010