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Director of Quality Assurance and Regulatory Affairs

Biomedical Search

Littleton, MA

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JOB DETAILS
SKILLS
Auditing, Continuous Improvement, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, FDA (Food and Drug Administration), FDA Requirements, ISO (International Organization for Standardization), Insurance Regulations, Leadership, Maintain Compliance, Manufacturing, Medical Equipment, Mentoring, Process Improvement, Product Development, Product Support, Quality Assurance, Quality Management, Quality Metrics, Regulations, Team Lead/Manager, Team Player, Vendor/Supplier Evaluation
LOCATION
Littleton, MA
POSTED
26 days ago
We are working with a growing medical technology company is seeking a Director of Quality & Regulatory Affairs to join its leadership team. This is an excellent opportunity for a hands-on leader who enjoys building teams, improving processes, and driving organizational growth in a fast-paced, collaborative environment.The Director will oversee Quality and Regulatory functions across multiple sites, ensuring compliance with FDA, ISO 13485, and other applicable regulations while partnering closely with Operations, Engineering, and Executive Leadership. This individual will play a key role in shaping quality strategy, strengthening the Quality Management System (QMS), leading audits and CAPA activities, and developing a high-performing QA/RA team.We're looking for someone who is highly engaged, approachable, and comfortable balancing strategic leadership with day-to-day operational involvement. The ideal candidate thrives in a growth-oriented environment where initiative, collaboration, and visibility are valued.What You’ll Be Doing
  • Lead Quality Assurance and Regulatory Affairs activities across multiple locations
  • Oversee QMS compliance, audits, CAPA, supplier quality, and regulatory programs
  • Drive continuous improvement initiatives and quality metrics
  • Partner with cross-functional teams to support product development and manufacturing
  • Mentor and develop Quality and Regulatory team members
  • Serve as a key member of the leadership team
What We’re Looking For
  • 10+ years of Quality and/or Regulatory experience in medical devices
  • Strong knowledge of FDA regulations, ISO 13485, and quality systems
  • Leadership experience managing teams and driving organizational change
  • Experience in manufacturing environments required
  • Regulatory Affairs and multi-site leadership experience preferred

About the Company

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Biomedical Search