VP, QA & Regulatory Affairs — Strategy & Compliance

Nihon Kohden America; Irvine (CA); On-site; USD 215,000 - 300,000; Full time

Job summary

Nihon Kohden America seeks a Vice President of Quality Assurance & Regulatory Affairs to lead QA, RA, compliance, and quality systems across the organization. This role integrates with the executive leadership team to drive strategic quality initiatives, regulatory submissions, and lifecycle management for medical devices.

Responsibilities include maintaining QMS per FDA/ISO/regulatory standards, leading CAPA and post-market activities, and partnering with NKC to align regulatory and product

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Biomedical Sciences, Quality, Regulatory Affairs, or a 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 and leading teams or projects.
• Demonstrated success leading FDA inspections and ISO 13485 surveillance and recertification audits.
• Experience with FDA 510(k) submissions and Health Canada licensing activities.
• Extensive knowledge of FDA QSRs (21 CFR Part 820), ISO 13485, and Health Canada Medical Device Regulations.
• Strong communication, strategic leadership and ability to influence executive leadership.
• Ability to balance regulatory compliance with commercial objectives.
• Ability to work effectively in a fast-paced, highly regulated environment.

Responsibilities

• Establishes and executes QA and RA strategies to support growth and lifecycle.
• Sits on Executive Leadership Team providing strategic counsel on quality, regulatory, and business risk.
• Promotes culture of quality, compliance, accountability, continuous improvement, and customer focus.
• Maintains QMS compliant with FDA, ISO 13485, Health Canada, and company requirements.
• Oversees CAPA, complaint handling, document control, training, change control, supplier quality, risk management, reviews.
• Leads continuous improvement and sets quality objectives and metrics.
• Develops regulatory strategies for US and Canada registrations and lifecycle management.
• Oversees FDA 510(k) submissions and Health Canada licensing activities.
• Ensures labeling, promotional materials, and regulatory documentation compliance.
• Liaises with NKC to align regulatory and quality initiatives.

Skills

Executive leadership

Strategic planning

Regulatory compliance

Quality systems

Cross-functional collaboration

Leadership communication

Regulatory affairs

Quality improvement

Education

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

Job description

Nihon Kohden America seeks a Vice President of Quality Assurance & Regulatory Affairs to lead QA, RA, compliance, and quality systems across the organization. This role integrates with the executive leadership team to drive strategic quality initiatives, regulatory submissions, and lifecycle management for medical devices.

Responsibilities include maintaining QMS per FDA/ISO/regulatory standards, leading CAPA and post-market activities, and partnering with NKC to align regulatory and product