Sr Director, Corporate Quality, Regulatory & Product Compliance
About The Position
The Senior Director, Corporate Quality, Regulatory & Product Compliance owns global Regulatory, Safety, Compliance, and Product/Service Life Cycle Management (PLCM) including the Quality Management System, and the product gating process across the enterprise. This leader ensures the delivery of safe, compliant, reliable, and high‑quality products, while enabling scalable, data‑driven operations through modern digital and AI‑enabled quality systems. This role leads enterprise frameworks for regulatory compliance, product safety engineering, ISO/QMS, and PLCM governance, and drives the adoption of advanced analytics, automation, and AI to proactively manage risk, accelerate time‑to‑market, and improve operational predictability.
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.
Nice To Haves
- Advanced degree in Engineering, Quality, Operations, or Regulatory Affairs.
- Experience implementing AI, automation, or advanced analytics in quality, compliance, or operations.
- Lean, Six Sigma, DFx, or reliability engineering expertise.
Responsibilities
- 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: o Intelligent document control o Continuous audit readiness o Process mining and compliance monitoring
- 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.
- Act as Secretary of the PLCM Steering Committee.
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
No Education Listed
Number of Employees
251-500 employees
