Director, Quality Assurance and Regulatory Affairs

The Director of RA/QA will lead the RA/QA function, providing guidance and leadership throughout all product development stages. This role involves establishing department operational objectives and budgets, managing staff hiring, assignments, performance feedback, and coaching. Responsibilities include developing, modifying, and executing RA/QA policies with company-wide effects, and managing department functions through direct reports. The position requires regular interaction with senior management, suppliers, and customers to collaborate, problem-solve, and gain acceptance in sensitive situations. Key duties include supporting the definition, training, and implementation of the quality management system (QMS) and its ongoing maintenance to ensure compliance with US and international regulatory requirements. The role also coordinates regulatory activities for design, development, NPI, manufacturing, distribution control, and service. Additionally, the Director will manage customer/service complaint reporting and investigation, review corrective actions and failure investigations, review Post Market Surveillance reporting, and implement field corrective actions as needed. This position serves as the designated Management Representative.