Vice President - Quality Assurance & Regulatory Affairs

Vice President - Quality & Regulatory Affairs

Our client is a dynamic, growing leader in the medical device industry. They are seeking a visionary and strategic VP of Quality and Regulatory Affairs to provide end-to-end oversight across all North American sites—from initial concept and R&D through manufacturing, commercialization, and post-market surveillance.

This role is ideally based out of the Boston, MA area however could have flexibility for California also and offers hybrid flexibility. Reporting directly to the NA President with a dotted line to the Global Head of QARA, you will harmonise regional quality management systems (QMS) and regulatory processes with global frameworks, driving a culture of absolute compliance and operational excellence.

• Strategic Leadership:
  Define and execute the North American QARA strategy, aligning regional objectives with global corporate goals.
• QMS Harmonisation:
  Implement and continuously mature global quality management policies and standards (FDA, ISO, GMP) across NA manufacturing and distribution sites.
• Regulatory Oversight:
  Act as the primary liaison with regulatory bodies (including the FDA), overseeing high-quality submissions, clearances (such as 510(k) s), and post-market vigilance.
• Audit & Compliance Management:
  Lead internal and external audits, ensuring optimal preparedness, swift investigations of non-conformances, and robust CAPA execution.
• Lifecycle Partnership:
  Collaborate closely with R&D, Operations, Commercial, and Service groups to ensure process consistency, product reliability, and risk mitigation from design to sunset.
• Team Stewardship:
  Mentor, guide, and inspire a matrixed regional QARA team, fostering a unified culture of continuous improvement.

• Experience:
  
  Minimum 15 years of experience in QARA management, including at least 10 years of senior leadership experience strictly within the medical device industry.
• Education:
  
  Bachelor’s degree in Life Sciences, Biotechnology, Engineering, or a related field. An advanced technical degree is strongly preferred.
• Technical Expertise:
  Comprehensive mastery of worldwide regulatory standards (ISO, QSR, GMP) and experience designing/measuring complex quality metrics.
• Soft Skills:
  
  Superior communication, critical thinking, and matrix-management capabilities. Must excel at collaborating across global, cross-functional teams and managing multi-time zone coordination.
• Systems (Preferred):
  Familiarity with digital enterprise systems like SAP is a plus.