Chief Quality & Regulatory Officer

Nihon Kohden North America, Inc.; Irvine (CA); Hybrid; USD 215,000 - 300,000; Full time

Job summary

Nihon Kohden America is seeking a strategic Vice President, Quality & Regulatory Affairs in Irvine, CA to lead QA, Regulatory and Compliance across product lifecycle. You will partner with NKC and the ELT to drive quality initiatives, ongoing compliance, and post-market activities for medical devices in the US and Canada.

Leverage extensive FDA 510(k) experience and ISO 13485 proficiency while guiding teams in CAPA, risk management, and supplier quality.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Biomedical Sciences, Quality, Regulatory Affairs, or 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 driving results through others, leading teams or projects, and providing training.
• Demonstrated success leading FDA inspections and BSI ISO 13485 surveillance and recertification audits.
• Significant experience with FDA 510(k) submissions, Health Canada licensing activities, and regulatory agency interactions.
• Extensive knowledge of FDA regulations, ISO 13485 requirements, Health Canada regulations, and medical device quality systems.
• Strong experience with complaint handling, CAPA, post-market surveillance, MDR, recalls, field actions, supplier quality, and risk management.
• Experience collaborating with global development, quality, and regulatory partners within a multinational organization.

Responsibilities

• Establishes and executes QA and Regulatory Affairs strategies to support business growth, customer satisfaction, product lifecycle management, and operational excellence.
• 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.
• Provides executive oversight for CAPA, complaint handling, document control, training, change control, supplier quality, risk management, and management review processes.
• Leads continuous improvement initiatives and establishes quality objectives, metrics, and performance indicators to strengthen organizational performance.
• Develops/regulates regulatory strategies for product registrations, market access, product modifications, software releases, and lifecycle management in US/Canada.
• Oversees FDA 510(k) submissions, Health Canada licensing activities, and other regulatory filings; ensures labeling and communications comply.
• Ensures compliance of product labeling, promotional materials, and regulatory documentation; monitors evolving regulatory requirements.
• Directs audit responses and remediation for FDA inspections, Health Canada assessments, and ISO 13485 audits.
• Supports commercial teams with quality/regulatory leadership for product launches, software updates, and lifecycle management.
• Drives training programs, policy adherence, and team development; ensures compliance with ethics standards.

Skills

Quality Leadership

Regulatory Strategy

FDA Inspections

ISO 13485

People Management

Regulatory Submissions

Risk Management

Cross-functional Collaboration

Education

Bachelor's degree in Engineering, Life Sciences, Biomedical Sciences, Quality, Regulatory Affairs, or related technical discipline

Job description

Nihon Kohden America is seeking a strategic Vice President, Quality & Regulatory Affairs in Irvine, CA to lead QA, Regulatory and Compliance across product lifecycle. You will partner with NKC and the ELT to drive quality initiatives, ongoing compliance, and post-market activities for medical devices in the US and Canada.

Leverage extensive FDA 510(k) experience and ISO 13485 proficiency while guiding teams in CAPA, risk management, and supplier quality.