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Myomo Logo Myomo · Quality Control

Director of Quality and Regulatory Affairs

United States, Burlington 170000.00 - 180000.00 USD / Year · Job Posted April 01, 2026
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Job Description

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.

Job Responsibility

  • Lead the global QA/RA function and is responsible for execution of the company’s quality and regulatory strategy
  • Ensure compliance with applicable global regulations and standards (including FDA and ISO requirements) and oversees quality systems across the product lifecycle
  • Partner cross-functionally to support product development, regulatory submissions, and ongoing compliance activities, while driving continuous improvement in quality processes
  • Contribute to the development and lead execution of the Quality strategy
  • 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
  • Ensure Quality Management System (QMS) processes are established, implemented, and maintained
  • Lead regulatory activities and compliance interactions, serving as the primary liaison with regulatory authorities
  • Oversee development and execution of global regulatory strategies for product submissions and lifecycle management
  • Monitor evolving global regulatory requirements and assess impact on the organization
  • 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
  • Ensure ongoing inspection readiness and manage external audits
  • Partner cross-functionally to ensure alignment of quality and regulatory requirements across product development, manufacturing, clinical and commercial activities
  • Present updates to senior leadership and, as needed, the Board of Directors
  • 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
  • Oversee post-market surveillance activities, including complaint handling, MDR/Vigilance reporting, and trend analysis
  • Ensure effective risk management processes
  • Lead cross-functional investigations, root cause analysis, and corrective/preventive action
  • Lead and develop the QA/RA team, including hiring, performance management, and coaching
  • Define roles, responsibilities, and performance expectations
  • Ensure effective resource planning and prioritization
  • Build and evolve team capabilities to support organizational growth and regulatory requirements

Requirements

  • 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
  • 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 equivalent is preferred
  • Experience operating in a high-growth or scaling organization
  • Strong communication (verbal and written), stakeholder management and cross-functional collaboration skills
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