Certification Name : Regulatory Affairs Certification – US
Certification ID & Type: 6103 – B – Advanced
Certification Description
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.
Certifying Organization
Regulatory Affairs Professionals Society(RAPS)(1046)
5635 Fishers Lane, Suite 500, Rockville, MD 20852
Contact information : 301-770-2920 Email : raps@raps.org
Organization Web Link
Certification Details
More than two years of education or training after high school required? Yes
More than two years of work experience required? Yes
Oral or Written Exam Required? Yes
Renewal Required? Every 3 Years
Renew through Continuing Educational Units(CEU)? Yes
Renew through Re-Examination? No
More Certification Information
Certification/ Career/ Job Keywords
healthcare, regulator