Certification: Regulatory Affairs Certification (RAC)

5635 Fishers Lane, Suite 500, Rockville, MD 20852

The RAC (GS) exam is intended for regulatory professionals with 3-5 years of experience and is largely based upon knowledge and application of regulatory functions throughout the healthcare product lifecycle. It covers all product areas, including medical devices, IVDs, pharmaceuticals, medicinal products and biologics. Also covered on the exam are international standards and guidelines including those of ICH, GHTF, WHO and ISO.

More than two years of education or training after high school required?
More than two years of work experience required?
Oral or Written Exam Required?
Renewal Required?
Every 3 Year(s)
Renew through Continuing Educational Units(CEU)?
Renew through Re-Examination?

Third Party Exam Center

Castle external site offers close to 1,000 test center locations in over 700 cities in over 70 countries that allow us to provide Internet-based and paper and pencil testing in a proctored environment.


The certification has an education level of an Associates of Arts or Associates of Sciences degree or higher and has a work experience requirement of more than 2 years, or requires obtaining a ‘core’ level certification from the same organization.

  • This certification is considered in demand.
  • This certification is accredited by the National Commission for Certifying Agencies (NCCA).
  • This certification is related to military occupational specialties.