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Regulatory Affairs Certification - US

certifying organization info

Regulatory Affairs Professionals Society
Regulatory Affairs Certification - US
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.

Regulatory Affairs Certification - US Website


Work Experience Required? Yes

Oral or Written Exam Required? Yes

Renewal Required? Every 3 Year(s)

Renew through Continuing Educational Units(CEU)? Yes

Renew through Re-Examination? No

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