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Nihon-Kohden

Chief Quality & Regulatory Affairs Leader

santa ana, CA

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About this opportunity

Nihon-Kohden lists this Chief Quality & Regulatory Affairs Leader opportunity in santa ana, California. Review the employer’s description below for duties, qualifications and application requirements.

Job description

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.

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Worksite address

santa ana, CA, 92725, US

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