What is Certification?
RAPS provides certification for the healthcare product RA community through its Regulatory Affairs Certification (RAC). The RAC designation is a mark of professional distinction. The RAC is indicative of the professional and technical abilities that are vital in this time of increasing challenges and demands within the health product sector. It also identifies individuals committed to excellence, pursuit of knowledge and career development.
RAC-credentialed professionals are among the current and rising leaders in regulatory affairs in industry, government and academic organizations. It is intended for the regulatory affairs professional with three to five years of regulatory experience.
Three different certifications are available: RAC (US) for US regulations, RAC (EU) for European regulations, and RAC (CAN) for Canadian regulations.
Why is Certification Desirable?
Certification sets those with the credential apart—or above—those without it. There are a number of advantages to seeking certification. Certification becomes a public recognition of professional achievement—both within and outside of the profession. For many, achieving certification becomes a personal professional goal—a way to test knowledge and to measure it against one’s peers. Others see certification as an aid to career advancement.
Exam Overview
- Three exams available: US, EU, and Canadian
- 100 multiple-choice questions for each of the RAC exams
- Two hours to complete each exam
- Administered by computer
- Administered only in English
The RAC Examinations (US, EU & CAN) are knowledge-based examinations addressing laws, regulations, policies and guidelines affecting regulated health products, including medical devices, pharmaceuticals, biologics and biotechnology in their respective regions. The examination is reviewed and revised annually.
Examination content is based on information effective December 31 of the prior year. For example, examinations administered in October/November 2008 includes regulations in effect 31 December 2007.
For a comprehensive description of the RAC examinations, including procedures, format and a content outline, download the Candidate Guide (468kb, pdf).
RAC Testing Dates and Locations
The RAC exams are administered twice a year in April/May and October/November. Because RAPS uses computer-based testing, exam-takers can choose from test dates within a two-month window of time in either period. See the table below the for testing windows and the deadlines for registration.
Exams can be taken in hundreds of US and international locations. Any of the three exams (US, EU, and Canadian) can be taken at any location.
| Testing Window |
Registration Deadline |
Late Deadline |
| 1 October – 31 November 2008 |
15 August 2008 |
8 September 2008 |
| 1 April – 31 May 2009 |
15 February 2008 |
8 March 2008 |
Recertification
RA professionals must recertify every three years to maintain the RAC credential. Recertification requires proof of your commitment to continuing education and professional development. For more information about the recertification process, review the RAC Recertification Guide (130kb, PDF) or visit the RAPS recertification page.
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