Head of DX Quality Management and Regulatory Affairs, LAM (Ciudad de México)

Head of DX Quality Management and Regulatory Affairs, LAM (Ciudad de México)

15 ago
|
Ith Icoserve
|
Ciudad de México

15 ago

Ith Icoserve

Ciudad de México

Head of DX Quality Management and Regulatory Affairs, LAM (IVD - Diagnostics)

Job ID

517038

Posted since

06-Aug-2026

Field of work

Quality Management

Company

Experienced Professional

Job type

Full-time

Hybrid (Remote/Office)

Employment type

Permanent

Location(s)
- Bogota - Bogota D.C. - Colombia

Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably.

Our inspiring and caring environment forms a integral community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions.

Mission and Position headline:

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.

Your tasks and responsibilities:

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.
- Ensure inspection readiness across all markets i

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

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