Overview of the Regulatory Affairs Certification (RAC) Global Scope Exam
The RAC-GS certification targets mid-to-senior regulatory affairs professionals tasked with navigating international medical device and pharmaceutical market authorization. Candidates must master global regulatory frameworks, including the EU Medical Device Regulation (MDR), FDA 21 CFR Parts 11, 210, and 211, and the International Council for Harmonisation (ICH) Q-series guidelines. Core technical objectives mandate the strategic application of Quality Management Systems (QMS) aligned with ISO 13485:2016 and GxP standards. Professionals must evaluate clinical trial data integrity, Post-Market Surveillance (PMS) protocols, and Vigilance Reporting requirements. Proficiency in Technical Documentation (STED) and electronic Common Technical Document (eCTD) submissions is essential for managing lifecycle compliance across disparate international jurisdictions.