VP, Quality & Regulatory Strategy

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

Job summary

Nihon Kohden America is seeking a strategic leader to direct Quality Assurance, Regulatory Affairs, Compliance, and Quality Systems. As a member of the Executive Leadership Team, you will shape QA/RA strategies, maintain the QMS per FDA/ISO standards, and partner with NKC to drive regulatory, quality, and post-market activities for US and Canada.

The role oversees FDA submissions, Health Canada licensing, CAPA, risk management, and supplier quality, ensuring scalable, compliant operations that

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Biomedical Sciences, Quality, Regulatory Affairs, or a related technical discipline. Equivalent combination of education and experience may be considered.
• 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, FDA Quality System Regulations (21 CFR Part 820), ISO 13485 requirements, and Health Canada Medical Device Regulations.
• Strong experience with complaint handling, CAPA, post-market surveillance, MDR, recalls, field actions, supplier quality, and risk management.
• Experience supporting commercial medical device organizations with sales, marketing, service, customer support, and product lifecycle responsibilities.
• Experience collaborating with global development, quality, and regulatory partners within a multinational organization.
• Experience supporting software-enabled and connected medical device products preferred.
• Level and compensation depend on location, experience, education and skills

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.
• Maintains an effective, compliant, and scalable Quality Management System (QMS) in accordance with FDA, ISO 13485, Health Canada, and company requirements.
• 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 regulatory strategies supporting product registrations, market access, product modifications, software releases, and lifecycle management within the US and Canada.
• Oversees preparation, review, and submission of FDA 510(k) applications, Health Canada licensing activities, and other required regulatory filings.
• Ensures compliance of product labeling, promotional materials, customer communications, and regulatory documentation while monitoring evolving regulatory requirements.
• Serves as the primary quality and regulatory liaison between Nihon Kohden America and Nihon Kohden Corporation (NKC).
• Drives alignment on product changes, software releases, complaint investigations, submissions, field actions, and lifecycle management strategies to support business objectives.
• Maintains inspection and audit readiness for FDA inspections and ISO 13485 surveillance; directs responses to audit findings and regulatory observations.

Skills

Executive leadership

Regulatory affairs

Quality management

FDA regulations

ISO 13485

Cross-functional collaboration

Risk management

Project management

Regulatory strategy

Software-enabled devices

People leadership

Education

Bachelor's degree in Engineering, Life Sciences, Biomedical Sciences, Quality, Regulatory Affairs

Job description

Nihon Kohden America is seeking a strategic leader to direct Quality Assurance, Regulatory Affairs, Compliance, and Quality Systems. As a member of the Executive Leadership Team, you will shape QA/RA strategies, maintain the QMS per FDA/ISO standards, and partner with NKC to drive regulatory, quality, and post-market activities for US and Canada.

The role oversees FDA submissions, Health Canada licensing, CAPA, risk management, and supplier quality, ensuring scalable, compliant operations that