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Learning Level: Advanced
Learning Level: Advanced
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Learning Level: Expert
Learning Level: Foundational
Learning Level: Foundational
Learning Level: Intermediate
Learning Level: Intermediate
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Student Focus

Seb Clerkin, PhD RAC (EU)

Director of Operations and Principle Consultant
GMP Advisory Services
Cork, Cork, Ireland

Seb Clerkin, PhD, RAC(EU), is an accomplished Medical Device Regulatory and Quality professional with extensive experience spanning European and U.S. regulatory affairs, quality management systems, design controls, validation, and clinical strategy. Based in Cork, Ireland, he advises both emerging innovators and established multinational organisations on regulatory compliance, submission strategy, audit readiness, and the practical implementation of robust quality systems. He is an IRCA-certified Lead Auditor and brings deep expertise across ISO 13485, 21 CFR Part 820, and EU MDR.

Seb is also a Faculty Member of AAMI, where he has contributed to the advancement of industry knowledge through training on Quality System Regulation, process validation, CAPA, risk management, and design controls. In addition, he has supported AAMI’s body of work through contributions to key publications, including the new QMS compendium 5th edition and other quality system resources. His work reflects a strong commitment to raising regulatory and quality standards across the medtech sector.

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Email Seb