Vice President, Quality Assurance & Regulatory Affairs

Vice President Of Quality Assurance And Regulatory Affairs

The Vice President of Quality Assurance and Regulatory Affairs (VP, QA/RA) provides leadership and strategic direction for the Company's Quality Assurance, Quality Control, and Regulatory Affairs functions. The VP, QA/RA is accountable for maintaining a robust and effective quality management system, ensuring regulatory compliance across the Company's product portfolio and markets, and establishing quality and regulatory strategies that support the Company's business objectives and continued growth.

This position serves as a member of the senior leadership team and provides strategic guidance on product development, manufacturing, quality, regulatory strategy, risk management, market expansion, and compliance. This is a hands-on executive leadership role in a focused medical device manufacturing environment. The VP, QA/RA will set strategy while remaining actively engaged in complex quality investigations, regulatory decisions, audits, product and manufacturing changes, and team development.

The VP, QA/RA serves as the Company's senior quality and regulatory authority and primary liaison with the FDA, notified bodies, certification organizations, international regulatory authorities, customers, and other external stakeholders. The role offers the direct impact and visibility of a close-knit operating company with the resources and global reach of the Nihon Kohden organization.

Executive Leadership & Organizational Management

• Provide strategic leadership and overall direction for Quality Assurance, Quality Control, and Regulatory Affairs.
• Establish the vision, priorities, objectives, and operating strategy for the QA/RA organization in alignment with Company's business and product strategies.
• Lead, develop, and retain a high-performing QA/RA organization, including managers and individual contributors.
• Establish clear accountability, performance expectations, organizational structure, and succession plans within the QA/RA function.
• Coach and develop leaders and employees while promoting a culture of quality, regulatory compliance, accountability, collaboration, and continuous improvement.
• Lead and oversee a QA/RA organization of approximately 25 direct and indirect employees; establish departmental goals, budgets, resource requirements, staffing plans, and performance metrics necessary to support Company objectives.
• Serve as a trusted advisor to the senior leadership team on quality, regulatory, compliance, and product risk matters.
• Provide executive-level recommendations and decision-making support regarding significant quality issues, regulatory risks, product changes, new products, and business opportunities.

Quality Management System & Quality Assurance

• Provide executive ownership and oversight of the Company's Quality Management System in accordance with FDA QMSR, ISO 13485, and other applicable regulatory and quality requirements.
• Ensure the Quality Management System effectively supports the full product lifecycle, including design and development, manufacturing, supplier management, production, distribution, servicing, and post-market activities.
• Establish and monitor annual quality objectives, key performance indicators, quality metrics, and continuous improvement initiatives.
• Oversee Quality Assurance and Quality Control activities, including design quality, manufacturing quality, receiving inspection, supplier quality, process controls, calibration, and product quality.
• Ensure effective management of CAPA, nonconformances, deviations, complaints, audit findings, and other quality system processes.
• Ensuring quality trends, systemic risks, and significant issues are appropriately escalated to senior leadership.
• Establish and maintain an effective internal audit program and ensure organizational readiness for FDA, notified body, certification, customer, and other external audits.
• Provide executive oversight of audit responses, corrective actions, root cause investigations, and timely closure of findings.
• Ensure the effectiveness and integrity of the Document Control and Change Control systems.
• Promote data-driven quality management and continuous improvement across the organization.

Regulatory Affairs

• Establish and execute regulatory strategies supporting the Company's current products, new product development, product changes, and expansion into domestic and international markets.
• Provide regulatory leadership for Class I and Class II medical devices, including product classification, regulatory pathways, pre-market submissions, registrations, clearances, approvals, and post-market requirements.
• Oversee regulatory compliance with applicable FDA requirements, including QMSR, device registration and listing, pre-market submissions, reporting requirements, recalls, labeling, and other applicable regulatory obligations.
• Serve as the primary executive contact for the FDA and other applicable regulatory authorities.
• Develop and oversee regulatory strategies, registrations, and market-entry requirements for international markets, including applicable European requirements and other markets in which the Company conducts business.
• Monitor changes in applicable regulations, standards, guidance, and regulatory expectations and proactively assess their impact on the Company.
• Provide regulatory direction and consultation to Engineering, Manufacturing, Clinical, Marketing, Sales, and other cross-functional teams.
• Ensure regulatory requirements are incorporated into product development, design changes, labeling, advertising, promotional claims, and product lifecycle activities.
• Oversee preparation for and response to regulatory inspections, audits, inquiries, and other regulatory interactions.

Product Quality, Compliance & Post-Market Oversight

• Provide executive oversight of customer complaints, adverse events, vigilance, and post-market surveillance systems.
• Ensure timely, accurate, and compliant evaluation and reporting of incidents and adverse events to applicable regulatory authorities.
• Oversee product risk assessments, quality investigations, complaint trending, and escalation of significant product or patient safety concerns.
• Ensure appropriate regulatory assessment of product changes, manufacturing changes, supplier changes, labeling changes, and other modifications.
• Establish appropriate processes for product recalls, field actions, corrections, and other regulatory or quality-related actions when necessary.
• Ensure compliance with product labeling, advertising, promotional materials, and regulatory claims.
• Establish and maintain appropriate export and international regulatory compliance processes.

Cross-Functional Leadership

• Partner closely with Engineering, Manufacturing, Clinical, Service, Sales, Marketing, and other functions to integrate quality and regulatory requirements into business decisions.
• Provide leadership in cross-functional decision-making involving product quality, regulatory strategy, customer requirements, manufacturing processes, and product risk.
• Serve as an executive sponsor for initiatives that improve product quality, regulatory compliance, operational effectiveness, and customer satisfaction.
• Promote a culture in which quality and regulatory compliance are shared organizational responsibilities rather than solely the responsibility of the QA/RA function.

Regulatory & Quality Risk Management

• Identify, evaluate, and communicate significant quality and regulatory risks to senior management.
• Establish appropriate risk-based approaches to quality and regulatory decision-making.
• Provide executive leadership during significant quality events, regulatory investigations, product complaints, recalls, inspections, or other compliance matters.
• Ensure timely and effective resolution of systemic quality and regulatory issues.
• Maintain awareness of emerging regulatory requirements and industry trends and proactively position the Company for future compliance needs.

Other Responsibilities

• Adhere to all Company policies, procedures, and applicable business ethics and compliance requirements.
• Perform other duties and responsibilities as assigned.

Qualifications

• Bachelor's degree in Regulatory Affairs, Quality Assurance, Engineering, Life Sciences, or related technical discipline.
• At least 8 years of progressive quality assurance experience and at least 5 years of regulatory affairs experience within the medical device industry.
• At least 5 years of demonstrated people-management and organizational leadership experience, including management of professional-level employees and/or managers.
• Demonstrated experience leading both Quality Assurance and Regulatory Affairs functions, preferably within a medical device manufacturing environment.
• Strong working knowledge of FDA QMSR, 21 CFR Part 820, ISO 13485, and applicable FDA medical device regulations.
• Strong understanding of international medical device regulatory requirements and experience supporting product registration or commercialization in international markets.
• Demonstrated experience with Class I and Class II medical devices and pre-market regulatory submissions.
• Demonstrated experience interacting directly with FDA, notified bodies, certification organizations, and/or international regulatory authorities.
• Strong experience managing Quality Management Systems, including CAPA, complaints, nonconformances, audits, supplier quality, document control, change control, and post-market surveillance.
• Experience leading FDA, notified body, ISO, customer, or other regulatory/quality audits and successfully managing responses and corrective actions.
• Demonstrated ability to assess complex quality and regulatory issues and provide sound, risk-based recommendations to senior leadership.
• Demonstrated success building, developing, and leading high-performing teams.
• Strong executive communication, presentation, negotiation