Head of DX Quality Management and Regulatory Affairs, LAM (IVD - Diagnostics)
Quality Management
Company
Full-time
Hybrid (Remote/Office)
Permanent
Join us in pioneering breakthroughs in healthcare. Our inspiring and caring environment forms a general community that celebrates diversity and individuality. Lead the Quality management & Regulatory Affairs function across the LAM region, ensuring compliance, product safety, and operational excellence across commercial operations and customer services.
Drive and execute regional quality and regulatory strategies, translating requirements into practical business actions that enable market access, customer satisfaction, and sustainable growth.
Serve as the Quality Representative for assigned legal entities and champion a pragmatic, risk-based approach that balances regulatory compliance with business objectives.
Quality Management & Continuous Improvement
Maintain and continuously improve the Quality Management System (QMS) to meet regulatory and business requirements.




Ensure effective execution of Quality Assurance and Quality Engineering processes (e.g., audits, training, documentation, CAPA, nonconformance management).
Identify and mitigate quality risks in commercial operations through structured risk management.
Drive process improvements that increase efficiency, product quality, and customer satisfaction.
Leverage digital tools and data insights to enhance quality performance, transparency, and decision-making.
Regulatory Strategy & Compliance
Define and execute the regional regulatory strategy that supports business growth objectives, ensuring timely submissions, approvals, and adherence to country-specific requirements.
Ensure full compliance with internal policies and external regulations, with a strong focus on product safety and market access. Commercial & Customer Quality
Establish governance framework, ensuring Commercial teams, Customer Services teams and Business Partners operate in accordance with local re

📌 Head of DX Quality Management and Regulatory Affairs, LAM (Ciudad de México)
🏢 Ith Icoserve
📍 Ciudad de México