Executive VP of Quality & Regulatory Excellence

NIHON KOHDEN OrangeMed; Santa Ana (CA); On-site; USD 190,000 - 230,000; Full time

Job summary

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.

Qualifications

• Bachelor's degree in engineering, life sciences, quality, regulatory affairs, or a related technical discipline.
• At least 8 years of progressive quality assurance experience and at least 5 years of regulatory affairs experience within the medical device industry or another highly regulated industry.
• At least five years of people leadership experience, including responsibility for professional-level employees and/or managers.
• Demonstrated experience leading both Quality Assurance and Regulatory Affairs responsibilities in a medical device manufacturing environment.

Responsibilities

• Lead OrangeMed’s Quality Assurance, Quality Control, and Regulatory Affairs functions.
• Serve as a trusted advisor to senior leadership on product quality, regulatory strategy, compliance, patient safety, and business risk.
• Maintain and continually improve the Quality Management System in accordance with FDA’s QMS Regulation under 21 CFR Part 820 and ISO 13485:2016.
• Provide direct quality leadership across design and development, design transfer, manufacturing, supplier management, inspection, distribution, servicing, and post-market activities.
• Oversee CAPA, nonconformances, deviations, complaints, change control, document control, supplier quality, audits, and post-market surveillance.
• Establish regulatory strategies for new products, product changes, manufacturing changes, and domestic and international market expansion.
• Lead or oversee FDA premarket submissions, product registrations, regulatory reporting, labeling compliance, and post-market obligations.

Skills

Leadership

Executive communication

Regulatory affairs knowledge

Quality assurance

Quality management systems

Risk management

Cross-functional collaboration

Education

Bachelor’s degree in engineering or life sciences

Master’s degree in engineering or life sciences

Job description

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.