Vice President Regulatory Affairs Quality Assurance (Irvine)
The Vice President, Quality Assurance & Regulatory Affairs is a member of the Executive Leadership Team responsible for the strategic direction, leadership, and execution of all Quality Assurance, Regulatory Affairs, Compliance, and Quality Systems activities for Nihon Kohden America. Serving as the Company's Management Representative, this position ensures the effectiveness and continuous improvement of the Quality Management System (QMS) while supporting the Company's sales, marketing, service, clinical support, and product lifecycle management activities. The Vice President serves as the primary liaison with regulatory authorities and certification bodies and partners closely with Nihon Kohden Corporation (NKC) to identify and implement the most efficient, compliant, and customer-focused approaches to regulatory, quality, and post-market activities. Essential Functions and Main Duties 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. Quality Management System Leadership Serves as the Company's Management Representative and 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. Regulatory Affairs Develops and executes regulatory strategies supporting product registrations, market access, product modifications, software releases, and lifecycle management activities within the United States 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. Partnership with Nihon Kohden Corporation (NKC) Serves as the primary quality and regulatory liaison between NKA and NKC. Collaborates with NKC Quality, Regulatory, Clinical, Engineering, and Product Development teams to execute regulatory and quality initiatives efficiently and compliantly. Drives alignment on product changes, software releases, complaint investigations, submissions, field actions, and lifecycle management strategies to support business objectives. Audit, Inspection, and Compliance Management Serves as the primary company representative for FDA inspections, Health Canada assessments, and BSI ISO 13485 surveillance and recertification audits. Maintains inspection and audit readiness while ensuring successful execution and follow-through of all regulatory and certification activities. Directs responses to audit findings, regulatory observations, nonconformities, and compliance commitments, including verification of corrective actions. Complaint Handling and Post-Market Activities Provides executive oversight of complaint handling, adverse event reporting, post-market surveillance, recalls, corrections, removals, and field actions. Leads investigation, root cause analysis, and corrective and preventive action activities associated with quality and compliance issues. Analyzes quality and customer feedback trends to improve product performance, customer satisfaction, and organizational effectiveness. Product Quality and Commercial Support Provides quality and regulatory leadership supporting Sales, Marketing, Service, Clinical, and Product Management activities. Supports commercialization efforts, product launches, software updates, and product lifecycle management while ensuring ongoing compliance. Drives customer-focused quality initiatives that improve product performance and the overall customer experience. Leadership and Talent Development Ensures effective quality and regulatory training programs and compliance with company policies, procedures, and ethical standards. Select, manage, develop, and hold accountable team members to meet department deliverables and responsibilities. Complete company people management requirements. Exhibit manager competencies. Adheres to all company policies, procedures, and business ethics codes. Duties may be modified or assigned at any time based on business need. Qualifications Education / Certification / Experience Required 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 experience 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 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 Executive leadership and strategic planning. Strong business acumen and sound decision-making capabilities. Extensive knowledge of FDA regulations, ISO 13485 requirements, Health Canada regulations, and medical device quality systems. 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. Demonstrated 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 and highly regulated environment. Proven ability to develop, motivate, and lead high-performing teams. High degree of integrity, professionalism, accountability, and sound judgment. Demonstrated ability to work effectively at both strategic and operational levels to achieve business and compliance objectives. Must be able to communicate verbally and in writing, and to receive and understand verbal and written instructions in English Able to work effectively both independently and in a collaborative team environment Compensation The anticipated range for this position is $215,000–$300,000. Actual placement within the range is dependent on multiple factors, including but not limited to skills, education, experience and location. Perks and Benefits Visit our Career page to learn more about Perks & Benefits and working at Nihon Kohden America Working Conditions Schedule: The regular hours for this full-time position are 8:00 a.m. to 5:00 p.m., Monday–Friday, unless otherwise stated by the department manager. Holiday, weekend, and evening work hours may be required. Regular hours may vary due to the needs of the organization or department and are subject to change at any time at the Company’s discretion. Physical: Generally, may require some reaching, bending, stooping, squatting, crawling, kneeling, pushing, pulling, lifting, carrying up to 20 pounds, finger dexterity, repetitive motions, standing, walking, sitting, hearing, visual acuity, color vision. More specific details may be provided as needed or requested. Reasonable accommodation may be requested by contacting Human Resources. Travel: Minimal, international travel to Japan J-18808-Ljbffr
