Job Description

Lead all Post Market Surveillance and complaint handling activities for the Guadalajara site, ensuring compliance with FDA, EU MDR, Health Canada, and other integral regulatory requirements.

Manage and develop a high-performing organization of approximately 70 employees, including supervisors, team leaders, and individual contributors.

Oversee complaint intake, assessment, reportability determinations, investigations, and timely case closure.

Monitor operational performance through metrics, dashboards, and trend analysis to identify risks, improve efficiency, and maintain compliance.

Drive continuous improvement initiatives, CAPAs, and quality system enhancements.





Act as the primary Quality Assurance and Regulatory Affairs representative for the Guadalajara location.

Support regulatory inspections, audits, and inquiries from competent authorities and notified bodies.

Collaborate closely with Customer Care, Product Support, Regulatory Affairs, Quality, and other cross-functional stakeholders globally.

Ensure effective training, talent development, succession planning, and workforce engagement.

Maintain awareness of emerging regulatory requirements and industry best practices related to post-market surveillance and medical device vigilance.

📌 Director, Post Market Surveillance (Ciudad de México)
🏢 Page Executive
📍 Ciudad de México