Quality Assurance & Regulatory Affairs Lead, SaMD

What you'll do

• Build and oversee QMS processes, including design controls, risk management, CAPA, audits, complaint handling, validation, and post-market monitoring.
• Assess intended use, device classification, regulatory pathways, clinical risk, and QMS needs for evolving software capabilities.
• Support regulatory submissions and maintain inspection readiness, quality metrics, audit responses, and continuous improvement.

What they ask for

• 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 technology, or medical devices.
• Strong command of medical device QMS processes and experience building and operationalizing QMS processes.
• Experience with software and AI/ML lifecycle expectations and understanding of applicable regulatory requirements, including FDA QMSR / 21 CFR Part 820, ISO 13485, ISO 14971, and IEC 62304.

Pay

$160,000 – $200,000 per year (base salary); $160,000 – $180,000 (base salary)

Tools

SaMD, AI/ML, 510(k), De Novo, FDA QMSR / 21 CFR Part 820, ISO 13485, ISO 14971, IEC 62304

AI focus

Governs quality and regulatory practices for AI-enabled medical device software, including AI/ML lifecycle governance, dataset governance, model performance evaluation, change control, and post-market monitoring.