Exam Name: Regulatory Affairs Certification (RAC) US
Certification Provider: RAPS
Corresponding Certification: RAC Regulatory Affairs Certification
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Instant Download RAPS : RAC-US Questions & Answers as PDF & Test Engine
Updated: Aug 03, 2026
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There are the topics covered by the RAPS RAC-US Certification Exam:
RAC-US exam dumps cover the following topics of the RAPS RAC-US Certification Exam:
- Medical Devices Regulations: 25%
- Pharmaceutical Regulations: 40%
- Medical Device Risk Management: 10%
- Drug Safety: 25%
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Following is the prerequisite for the RAPS RAC-US Certification Exam:
- You must have 3 to 5 years of experience in regulatory affairs.
- You must be a member of RAPS, the Regulatory Affairs Professionals Society
- You should have a Bachelor's degree or higher
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RAPS RAC-US Exam Syllabus Topics:
| Section | Weight | Objectives |
|---|---|---|
| Topic 1: Development and Pre-Market | 28% | - Design controls and technical documentation - Clinical trials and non-clinical studies - CMC and manufacturing requirements - Labeling and advertising regulations |
| Topic 2: Post-Market and Compliance | 24% | - Inspections, audits, and enforcement actions - Reporting obligations and adverse events - Compliance and continuous improvement - Post-marketing surveillance and pharmacovigilance |
| Topic 3: Strategic Planning | 24% | - Regulatory pathways and marketing authorization - US regulatory environment and framework - Product lifecycle strategy - Risk management and quality systems |
| Topic 4: Submissions and Regulatory Interactions | 24% | - FDA review processes and communications - Modifications, supplements, and variations - eCTD and electronic submission formats - Regulatory intelligence and planning |
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