Director of Quality & Regulatory Affairs

Director of Quality & Regulatory Affairs Department: Quality Employment Type: Full Time Location: Burlington, MA Compensation: $170,000 - $180,000 / year Description Why should you join our success story? Based on patented technology developed at MIT, Harvard Medical School and by the Company, Myomo develops and markets the MyoPro® product line of lightweight, non-invasive, powered arm braces (orthoses) to restore function in paralyzed or weakened arms and hands of individuals that have suffered a stroke, spinal cord, or nerve injury. (E.g. brachial plexus injury or other neuro-muscular disabilities.) It is the only device that, sensing a patient’s own neurological signals through non-invasive wearable sensors, can restore the ability to use their arms and hands so that they can live independently, increase their quality of life, reduce cost of care, and return to work. Published clinical research shows a clinically significant instantaneous reduction in upper extremity impairment with the MyoPro. Our technology has been referred by leading-edge rehabilitation facilities including Mayo Clinic, Kennedy Krieger Institute, Cleveland Clinic, Loma Linda Medical Center, Massachusetts General Hospital, numerous VA Hospitals, and more. Myomo is headquartered in Burlington, Massachusetts, with sales and clinical professionals across the U.S. What we’re looking for: The Director of Quality and Regulatory Affairs leads the global QA/RA function and is responsible for execution of the company’s quality and regulatory strategy. This role ensures compliance with applicable global regulations and standards (including FDA and ISO requirements) and oversees quality systems across the product lifecycle. The Director partners cross-functionally to support product development, regulatory submissions, and ongoing compliance activities, while driving continuous improvement in quality processes. How You'll Drive Impact: QA/RA Strategic Alignment & Operational Leadership In collaboration with senior leadership, contribute to the development and lead execution of the Quality strategy aligned with the Company size, development stage and business needs. Lead departmental planning and budgeting, optimizing resources and operational efficiency. Direct QA/RA staff, including organizational design, talent development and performance management. Develop and continuously improve quality programs, policies, and processes to support product performance and customer satisfaction. Ensure Quality Management System (QMS) processes are established, implemented, and maintained with a focus on compliance, effectiveness and scalability. Regulatory Strategy & Compliance Lead regulatory activities and compliance interactions, serving as the primary liaison with regulatory authorities, including the FDA and notified bodies. Act as management representative and/or person responsible for regulatory compliance. Oversee development and execution of global regulatory strategies for product submissions and lifecycle management (e.g., CE Mark, technical documentation). Monitor evolving global regulatory requirements and assess impact on the organization, adjusting plans as needed. Ensure compliance with FDA QMSR (Part 820), ISO 13485, EU MDR, and other applicable global regulations and standards. Review advertising and promotional marketing materials for regulatory compliance. Maintain global product regulations and change notifications. Quality Systems Own and maintain the effectiveness of the Quality Management System (QMS). Ensure robust and compliant processes for CAPA, complaint handling, document control, risk management and supplier quality. Lead management review processes and quality metrics reporting, driving continuous improvement across the organization. Ensure ongoing inspection readiness and manage external audits (FDA, ISO, notified bodies). Organizational Leadership & Cross-Functional Collaboration Partner cross-functionally to ensure alignment of quality and regulatory requirements across product development, manufacturing, clinical and commercial activities, including oversight of Design Controls, validation, and supplier quality. Present updates to senior leadership and, as needed, the Board of Directors on Quality and Regulatory performance, risks, and compliance status. Report on QMS effectiveness and identify opportunities for continuous improvement. Promote awareness of quality and regulatory requirements across the organization. Ensure activities are conducted in compliance with applicable regulations, company policies, and ethical standards. Post-Market & Risk Management Oversee post-market surveillance activities, including complaint handling, MDR/Vigilance reporting, and trend analysis. Ensure effective risk management processes in alignment with ISO 14971. Lead cross-functional investigations, root cause analysis, and corrective/preventive action Management Lead and develop the QA/RA team, including hiring, performance management, and coaching. Define roles, responsibilities, and performance expectations aligned with business objectives. Ensure effective resource planning and prioritization to meet project and compliance needs. Build and evolve team capabilities to support organizational growth and regulatory requirements. What You'll Bring: Bachelor’s degree in a scientific, technical, or related discipline; advanced degree preferred. 8-10+ years of progressive experience in Quality Assurance and Regulatory Affairs within the medical device industry, including significant management experience. 5+ years of experience with Class I and/or Class II medical devices. Experience operating within FDA-regulated cGMP environments, including regulatory submissions and agency interactions. Strong knowledge of FDA 21 CFR Part 820/QMSR, ISO 13485, EU MDR, ISO 14971, and Design Controls. Experience managing Quality Management Systems (QMS) for medical devices (Ketryx preferred) Experience supporting global regulatory activities (e.g., EU, Canada, APAC preferred). Demonstrated experience leading QA/RA teams, including talent development and performance management. RAC certification or equivalentis preferred. Experience operating in a high-growth or scaling organization. Strong communication (verbal and written), stakeholder management and cross-functional collaboration skills. #J-18808-Ljbffr Myomo, Inc