Executive VP, Quality & Regulatory Affairs

Nihon Kohden; Irvine (CA); On-site; USD 215,000 - 300,000; Full time

Job summary

Nihon Kohden America is seeking a Vice President of Quality & Regulatory Affairs to lead the Quality Assurance, Regulatory Affairs, and Quality Systems functions. The role reports to the Executive Leadership Team and partners with Nihon Kohden Corporation to align regulatory, quality, and post-market activities across the organization.

The position oversees FDA/ISO regulatory compliance, CAPA, complaint handling, document control, and product lifecycle management while ensuring customer-focused

Qualifications

• Bachelor7s degree in Engineering, Life Sciences, Biomedical Sciences, Quality, Regulatory Affairs, or a related technical discipline.
• 15+ years of progressive Quality Assurance and Regulatory Affairs experience within the medical device industry.
• 10+ years of people management experience, including leading teams or projects and providing training.
• Demonstrated success leading FDA inspections and ISO 13485 surveillance and recertification audits.
• Significant experience with FDA 510(k) submissions, Health Canada licensing activities, and regulatory agency interactions.

Responsibilities

• Establishes and executes Quality Assurance and Regulatory Affairs strategies that support business growth, customer satisfaction, product lifecycle management, and operational excellence.
• Serves as a member of the Executive Leadership Team, providing strategic counsel regarding quality, regulatory, compliance, and business risk matters.
• Promotes a culture of quality, compliance, accountability, continuous improvement, and customer focus throughout the organization.
• Leads continuous improvement initiatives and establishes quality objectives, metrics, and performance indicators to strengthen organizational performance.

Job description

Nihon Kohden America is seeking a Vice President of Quality & Regulatory Affairs to lead the Quality Assurance, Regulatory Affairs, and Quality Systems functions. The role reports to the Executive Leadership Team and partners with Nihon Kohden Corporation to align regulatory, quality, and post-market activities across the organization.

The position oversees FDA/ISO regulatory compliance, CAPA, complaint handling, document control, and product lifecycle management while ensuring customer-focused