Chief Quality & Regulatory Affairs Leader

Nihon Kohden Orange Med is seeking a visionary Vice President of Quality Assurance & Regulatory Affairs to lead QA, QC, and Regulatory Affairs. This executive will define strategies, ensure compliance with FDA QMSR, ISO 13485, and guide risk management, product changes, and market expansion. The role requires building and steering a high-performing QA/RA team, managing audits, CAPA, and regulatory submissions while aligning with corporate objectives and growth.