Regulatory Affairs

Regulatory Affairs professionals work at the interface of industry and government to help ensure that biomedical technologies are safe, effective, high quality, and correctly labeled and marketed. You will help protect the public by evaluating the safety and efficacy of healthcare products before and after commercial release.

Interested in Regulatory Affairs? Check out our overview of this career at the link below for more information on this career and the skills you will need to succeed.

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Gain Skills and Experience

Writing Course

Take a regulatory writing course from the PDP. Clinical documents discussed include clinical trial protocols, clinical trial informed consents (ICFs), investigator brochures (IBs), and clinical study reports (CSRs) among others.

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Regulatory Affairs Certification

The Regulatory Affairs Certification (RAC) is the only certification specifically for regulatory professionals in the healthcare product sector, which is obtained by passing a rigorous exam. Learn the regulations that apply to drugs, biologics or medical devices.

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U.S. Food and Drug Administration

Complete online tutorials, classes or internships at the FDA.

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FDA - Regulation Changes

Sign up for FDA updates on regulation changes.

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Regulatory Guidelines

Familiarize yourself with regulatory guidelines.

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