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 Certification (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.

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.
  • Exams are updated annually. Exams taken in the spring 2022 will be based on 31 December 2020 regulations. Exams taken in summer 2022 and fall 2022, will be based on 31 December 2021 regulations.
  • 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 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*)

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 outlines. Each examination content outline contains the content domains, competency statements and number of questions in each domain.

Assess the scope and depth of your knowledge and experience. Use the content outline as a checklist and 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.

Get RAC Prep Tools

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

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

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!

Download the Justification Letter

Regulatory Affairs Professionals Society (RAPS)
5635 Fishers Lane, Suite 400
Rockville, MD 20852
P +1 301 770 2920 | F +1 301 841 7956
Email: raps@raps.org

© 2021 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
credential maintenance

Encourages development of a more productive and highly
trained workforce

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.

Get Yours 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 computer 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).
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.
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.
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.
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

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