Director of Quality Systems & Regulatory Affairs

Job Summary

To strengthen and scale the organization's quality and regulatory infrastructure, the full-time Director of Quality Systems & Regulatory Affairs will manage the electronic Quality Management System (eQMS), lead audit and compliance initiatives, and provide strategic regulatory leadership while working remotely from the East Coast.

Key responsibilities

• Serve as the system owner for the eQMS platform, optimizing and expanding its implementation and governance
• Act as the primary Quality and Regulatory lead during audits and inspections, ensuring continuous organizational readiness
• Independently manage FDA and international regulatory submissions, providing strategic recommendations and maintaining regulatory records

Required qualifications

• Bachelor's degree in Engineering, Life Sciences, Regulatory Affairs, Quality, or a related field; advanced degree preferred
• 8-12+ years of progressive Quality and Regulatory Affairs experience within medical devices
• Proven experience owning or improving an electronic QMS platform, with Greenlight Guru experience strongly preferred
• Demonstrated experience leading FDA submissions and EU MDR activities, along with audit preparation and remediation
• Deep understanding of ISO 13485, FDA Quality System Regulation, and EU MDR regulations