Senior Director, Corporate Quality, Regulatory & Product Compliance

Role Overview

• Own and evolve the global regulatory compliance strategy across all regions and product lines.
• Leverage AI‑enabled regulatory intelligence tools to monitor regulatory changes and assess product impact.
• Ensure compliance with UL, FCC, CE, RoHS, REACH, Prop 65, and other applicable standards.
• Lead regulatory audits, certifications, and technical submissions using digitized compliance evidence systems.
• Embed compliance requirements early in product architecture through close partnership with Engineering and Product teams.
• Lead the corporate product safety program, including hazard analysis, FMEA, risk mitigation, and field actions.
• Deploy data‑driven and AI‑assisted risk assessment methods to identify emerging safety issues.
• Oversee investigations, RCA, and CAPA using advanced analytics across field, manufacturing, and reliability data.
• Establish predictive safety metrics and dashboards for executive review.
• Own enterprise ISO frameworks (ISO 9001, 14001, 45001, etc.).
• Lead the transformation toward a digital, AI‑enabled QMS, including intelligent document control and continuous audit readiness.
• Partner with global functions and manufacturing partners to ensure consistent QMS execution.
• Own and govern the enterprise PLCM framework and stage‑gate process.
• Implement AI‑driven launch readiness and risk scoring across NPI programs.
• Provide executive visibility through integrated dashboards, predictive KPIs, and automated gate reviews.
• Champion a quality‑first, data‑driven, and AI‑augmented culture across Engineering, Operations, Supply Chain, and Service.
• Drive KPI governance using advanced analytics and trend‑based insights.
• Influence senior leaders through clear, evidence‑based recommendations.

Requirements

• 10 + years of experience in Quality, Regulatory, Product Safety, PLCM, or NPI in a hardware or regulated industry.
• Proven experience scaling global quality and compliance programs.
• Strong understanding of digital QMS, analytics, and AI applications in quality and operations.
• Experience engaging engineering‑led organizations and executive leadership.
• Experience managing contract manufacturers globally.
• Advanced degree in Engineering, Quality, Operations, or Regulatory Affairs (preferred).
• Experience implementing AI, automation, or advanced analytics in quality, compliance, or operations (preferred).
• Lean, Six Sigma, DFx, or reliability engineering expertise (preferred).

Benefits

• Health insurance
• Retirement plans
• Paid time off
• Flexible work arrangements
• Professional development
• Bonuses
• Equity