Quality & Regulatory Operations Lead

5+ years of Quality Systems experience and Software as a Medical Device (SaMD) experience 3+ years in a project management or technical leadership role Experience working in a regulated agile development environment Expert familiarity with medical device CAPA regulations and requirements Familiarity with global medical device regulations (QSR/QMSR, MDD/CMDR/MDR) Strong understanding of ISO 13485, ISO 14971, IEC 62304, GDPR, HIPAA, and related standards

Organize and manage timely completion of QARA tasks, including CAPAs and DHF deliverables Coordinate due dates, dependencies, and status updates to align QARA work with project schedules Maintain teamwide deliverable trackers with owners, due dates, and dependencies Partner with deliverable owners to keep status current and identify risks early Interface with project leaders, RA, and Quality teams to clarify ownership and escalate risks Ensure QARA deliverables related to design control release timing are tracked by phase Coordinate the transition to new DHF/DDS templates during QMSR implementation Utilize eQMS and ALM systems to ensure deliverables are properly stored and audit-ready Analyze performance data, tools, and templates to identify operational improvements Assist with international regulatory submissions and global conformity assessment needs Coordinate the company-wide CAPA system Lead CAPA investigations, corrections, corrective actions, preventive actions, and effectiveness checks Host CAPA CRB meetings and present CAPA content during internal and external audits Conduct CAPA training as needed Perform other QARA-related duties as assigned (e.g., validation of QARA applications)