Quality & Regulatory Affairs Lead

📋 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