Executive VP of Quality & Regulatory Excellence

NIHON KOHDEN OrangeMed · Santa ana, United States

Nihon Kohden OrangeMed, based in Santa Ana, California, seeks a Vice President of Quality Assurance and Regulatory Affairs to lead QA, QA, and Regulatory Affairs with direct hands-on involvement in investigations, regulatory decisions, and audits.

The ideal leader will drive the Quality Management System under 21 CFR Part 820 and ISO 13485:2016, manage end-to-end regulatory programs, and collaborate with engineering, manufacturing, and commercial teams to ensure patient safety and compliance.