Chief Quality & Regulatory Affairs Leader

Nihon-Kohden; Santa Ana (CA); On-site; USD 190,000 - 230,000; Full time

Job summary

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.

Qualifications

• Bachelor’s degree in Regulatory Affairs, Quality Assurance, Engineering, Life Sciences, or 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.
• Demonstrated experience leading QA/RA functions, preferably within medical devices.

Responsibilities

• Provide executive leadership for QA, QC, and Regulatory Affairs.
• Establish and implement regulatory strategies for domestic and international markets.
• Oversee CAPA, nonconformances, audits, and post-market surveillance.
• Lead cross-functional teams and liaise with FDA and other authorities.

Skills

Executive leadership

Regulatory strategy

Quality management

Cross-functional collaboration

Regulatory affairs

Education

Bachelor’s degree in Regulatory Affairs, Quality Assurance, Engineering, Life Sciences, or related

Master’s degree (preferred)

Tools

FDA QMSR

ISO 13485

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.