Vice President, Quality & Regulatory Affairs

Nihon Kohden America•Irvine, CA

About The Position

The Vice President, Quality Assurance & Regulatory Affairs is a member of Nihon Kohden America’s Executive Leadership Team and is responsible for the strategic direction, leadership, and execution of Quality Assurance, Regulatory Affairs, Compliance, and Quality Systems activities. As the Company’s Management Representative, this leader maintains the effectiveness and continuous improvement of the Quality Management System (QMS), while supporting sales, marketing, service, clinical support, and product lifecycle management. The role is the primary liaison with regulatory authorities and certification bodies and partners closely with Nihon Kohden Corporation (NKC) on efficient, compliant, and customer-focused quality, regulatory, and post-market activities. The position develops and executes quality and regulatory strategies; oversees QMS processes, regulatory submissions, audits, inspections, complaint handling, and post-market activities; and supports product commercialization and lifecycle management. It also leads and develops the quality and regulatory team, promotes a culture of quality and compliance, and works across executive, commercial, and global partner groups to meet business and compliance objectives.

Requirements

Bachelor’s degree in Engineering, Life Sciences, Biomedical Sciences, Quality, Regulatory Affairs, or a related technical discipline; an equivalent combination of education and experience may be considered.
15 or more years of progressive Quality Assurance and Regulatory Affairs experience in the medical device industry.
10 or more 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, Medical Device Reporting (MDR), recalls, field actions, supplier quality, and risk management.
Experience supporting commercial medical device organizations across sales, marketing, service, customer support, and product lifecycle responsibilities.
Experience collaborating with global development, quality, and regulatory partners within a multinational organization.
Executive leadership and strategic planning capabilities, strong business acumen, and sound decision-making.
Ability to balance regulatory compliance requirements with commercial business objectives.
Excellent analytical, problem-solving, root cause analysis, and risk assessment skills.
Exceptional written, verbal, presentation, and interpersonal communication skills.
Ability to influence executive leadership and drive alignment across diverse stakeholder groups.
Strong project management, organizational, and change management capabilities.
Ability to manage multiple priorities in a fast-paced, highly regulated environment.
Proven ability to develop, motivate, and lead high-performing teams.
High degree of integrity, professionalism, accountability, and sound judgment.
Ability to work effectively at strategic and operational levels, independently and collaboratively.
Ability to communicate verbally and in writing in English and to receive and understand verbal and written instructions in English.

Nice To Haves

Experience supporting software-enabled and connected medical device products.

Responsibilities

Establish and execute Quality Assurance and Regulatory Affairs strategies that support business growth, customer satisfaction, product lifecycle management, and operational excellence.
Serve on the Executive Leadership Team and provide strategic counsel on quality, regulatory, compliance, and business risk matters.
Promote a culture of quality, compliance, accountability, continuous improvement, and customer focus.
Serve as the Company’s Management Representative and maintain an effective, compliant, and scalable QMS in accordance with FDA, ISO 13485, Health Canada, and company requirements.
Provide executive oversight for CAPA, complaint handling, document control, training, change control, supplier quality, risk management, and management review.
Lead continuous improvement initiatives and establish quality objectives, metrics, and performance indicators.
Develop and execute regulatory strategies for product registrations, market access, product modifications, software releases, and lifecycle management in the United States and Canada.
Oversee preparation, review, and submission of FDA 510(k) applications, Health Canada licensing activities, and other regulatory filings.
Ensure compliance of product labeling, promotional materials, customer communications, and regulatory documentation, and monitor evolving regulatory requirements.
Serve as the primary quality and regulatory liaison between NKA and NKC; collaborate with NKC Quality, Regulatory, Clinical, Engineering, and Product Development teams.
Drive alignment with NKC on product changes, software releases, complaint investigations, submissions, field actions, and lifecycle management strategies.
Represent the company in FDA inspections, Health Canada assessments, and BSI ISO 13485 surveillance and recertification audits.
Maintain inspection and audit readiness and direct responses to audit findings, regulatory observations, nonconformities, and compliance commitments, including corrective-action verification.
Provide executive oversight of complaint handling, adverse event reporting, post-market surveillance, recalls, corrections, removals, and field actions.
Lead investigations, root cause analysis, and corrective and preventive actions related to quality and compliance issues.
Analyze quality and customer feedback trends to improve product performance, customer satisfaction, and organizational effectiveness.
Provide quality and regulatory leadership to Sales, Marketing, Service, Clinical, and Product Management.
Support commercialization, product launches, software updates, and product lifecycle management while ensuring ongoing compliance.
Drive customer-focused quality initiatives to improve product performance and the customer experience.
Ensure effective quality and regulatory training programs and compliance with company policies, procedures, and ethical standards.
Select, manage, develop, and hold team members accountable for department deliverables and responsibilities.
Complete company people-management requirements, exhibit manager competencies, and adhere to company policies, procedures, and business ethics codes.
Perform other duties as modified or assigned based on business needs.