Vice President, Quality & Regulatory Affairs

Vice President, Quality & Regulatory Affairs

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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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…