Job Description
📋 Description Own QMS strategy and regulatory model for AI-enabled software and SaMD. Lead quality governance across design controls, CAPA, audits, and post-market monitoring. Process owner for policy governance and patient incident intake with Compliance. Collaborate with Product, Engineering, Data Science, Clinical, Security, Legal, Compliance on use, risk, and regulatory needs. Establish risk-based SDLC controls, traceability, V&V, usability, release readiness, and AI/ML lifecycle governance. Support regulatory strategy and submissions for AI-enabled device software (510(k), De Novo) including docs. 🎯 Requirements 10+ years of progressive experience in Quality Assurance, Regulatory Affairs, Quality Systems, or Quality Compliance, with leadership across software, product, clinical, and technical teams. Deep experience in regulated software, digital health, SaMD, AI-enabled medical device software, healthcare tech, or medical devices. Strong command of medical device QMS: design controls, risk mgmt, CAPA, audits, document control, and management review. Experienced building and operationalizing QMS processes, training teams, appointing process owners, and preparing for external review. Experience with software/AI/ML lifecycles: requirements mgmt, V&V, model performance, data governance, change control, post-market monitoring, risk-based release. Deep understanding of FDA QMSR / 21 CFR 820, ISO 13485, 14971, IEC 62304, cybersecurity expectations. 🎁 Benefits Competitive pay & equity Fully remote Comprehensive health coverage: medical, dental and vision Paid time off 401k plan + matching Home office stipend
