Quality & Regulatory Affairs Lead

What You'll Do:

• Own Cadence's QMS strategy and regulatory operating model for AI-enabled healthcare software, SaMD, clinical decision support, and technology-enabled care workflows.
• Lead quality system governance across design controls, risk management, CAPA, change control, document control, training, supplier quality, validation / computer software assurance, audit readiness, complaint handling, and post-market quality monitoring.
• Serve as process owner for policy governance and patient incident / feedback intake, triage, escalation, documentation, and closure with Compliance leadership.

What You Need:

• 10+ years of progressive experience in Quality Assurance, Regulatory Affairs, or Quality Compliance with leadership experience in regulated software, digital health, SaMD, or AI-enabled medical device environments.
• Strong command of medical device QMS processes including design controls, risk management, CAPA, audits, document control, training, supplier quality, complaint handling, and change control.
• Deep understanding of FDA QMSR / 21 CFR Part 820, ISO 13485, ISO 14971, IEC 62304, and FDA software guidance.

Compensation & Benefits:

• Salary range: $160,000 – $200,000 per year plus equity options.
• Comprehensive health benefits including medical, dental, and vision.
• 401(k) plan with matching, paid parental leave, and home office stipend.