Executive VP of Quality & Regulatory Affairs

Nihon Kohden America; Irvine (CA); On-site; USD 180,000 - 260,000; Full time

Job summary

Nihon Kohden America seeks a Vice President of Quality Assurance & Regulatory Affairs to lead QA, regulatory compliance, and quality systems. This Executive role partners with NKC and cross‑functional teams to ensure product lifecycle excellence and patient safety.

The ideal candidate has extensive experience in FDA/regulatory affairs for medical devices, leads regulatory submissions (FDA 510(k) and Health Canada), and builds a culture of continuous improvement across global operations.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Biomedical Sciences, Quality, Regulatory Affairs, or related field.
• 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.
• 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.
• Extensive knowledge of FDA regulations, 21 CFR Part 820, ISO 13485, and Health Canada Medical Device Regulations.
• Experience supporting commercial medical device organizations with sales, marketing, service, and product lifecycle responsibilities.
• Experience collaborating with global development, quality, and regulatory partners in a multinational organization.
• Experience supporting software-enabled and connected medical device products preferred.

Responsibilities

• Establish QA and regulatory strategies that support growth, customer satisfaction, product lifecycle management, and operational excellence.
• Serve as Executive Leadership Team member, providing strategic counsel on quality, regulatory, compliance, and business risk matters.
• Promote a culture of quality, compliance, accountability, continuous improvement, and customer focus.
• Maintain an effective QMS in accordance with FDA, ISO 13485, Health Canada, and company requirements.
• Oversee CAPA, complaint handling, document control, training, change control, supplier quality, risk management, and management review processes.
• Lead regulatory strategies for product registrations, market access, and lifecycle management in the US and Canada.
• Ensure compliance of product labeling, promotional materials, and regulatory documentation.
• Direct responses to audit findings and regulatory observations, including verification of corrective actions.

Skills

Executive leadership

Regulatory affairs

Quality Assurance

Compliance

Risk management

Project management

Communication

Education

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

Job description

Nihon Kohden America seeks a Vice President of Quality Assurance & Regulatory Affairs to lead QA, regulatory compliance, and quality systems. This Executive role partners with NKC and cross‑functional teams to ensure product lifecycle excellence and patient safety.

The ideal candidate has extensive experience in FDA/regulatory affairs for medical devices, leads regulatory submissions (FDA 510(k) and Health Canada), and builds a culture of continuous improvement across global operations.