Bachelor's degree in a scientific or technical field; advanced degree preferred.
8-10+ years in Quality Assurance and Regulatory Affairs in the medical device industry, with significant management experience.
5+ years of experience with Class I and/or Class II medical devices.
Strong knowledge of FDA regulations (21 CFR Part 820/QMSR), ISO 13485, EU MDR, and ISO 14971.
Experience managing Quality Management Systems (QMS) for medical devices, preferably Ketryx.
RAC certification or equivalent preferred.
Experience in high-growth or scaling organizations.
Responsibilities
Lead the global QA/RA function and execute the company's quality and regulatory strategy.
Develop and implement quality programs, policies, and processes to enhance product performance.
Oversee regulatory activities and serve as the primary liaison with regulatory authorities.
Ensure compliance with global regulations and standards, including FDA and ISO requirements.
Manage post-market surveillance activities and risk management processes.
Drive continuous improvement in quality processes and metrics reporting.
Collaborate cross-functionally to align quality and regulatory requirements across various departments.
Benefits
Full-time position with a focus on leadership and strategic impact.
Opportunity to shape the quality and regulatory landscape of a growing organization.
Engagement with senior leadership and the Board of Directors on critical compliance issues.
Potential for professional development and team building in a high-growth environment.
Full Job Description
Director of Quality & Regulatory Affairs
Department: Quality
Employment Type: Full Time
Location: Burlington, MA
Compensation: $170,000 - $180,000 / year
Description
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.
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.
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.
