Global Director, Post-Market Surveillance & Quality

Page Executive; Región Centro; Presencial; Confidencial; Jornada completa

Descripción de la vacante

Page Executive seeks a Director of Post Market Surveillance in Guadalajara to lead the global quality and compliance function for a medical technology leader. You will oversee a ~70-person team, manage post-market activities, regulatory interactions, CAPAs, and continuous improvement while ensuring patient safety and regulatory conformity across FDA, EU MDR, Health Canada and other authorities.

Fluent English required.

Formación

• Extensive experience in post-market surveillance within life sciences.
• Strong knowledge of regulatory requirements and compliance standards.
• 12+ years in medical devices or life sciences, incl. 8+ in leadership.
• Proven ability to lead large teams in a global matrix environment.
• Fluency in English; excellent stakeholder management and communication.

Responsabilidades

• Lead Post Market Surveillance and complaint handling for Guadalajara.
• Ensure compliance with FDA, EU MDR, Health Canada and global authorities.
• Manage a ~70-person organization with supervisors and individual contributors.
• Oversee intake, assessment, investigations, and case closure.
• Drive CAPAs and quality system enhancements; monitor metrics and trends.
• Support regulatory inspections, audits, and inquiries.
• Collaborate with cross-functional stakeholders globally.
• Invest in training, talent development and succession planning.

Conocimientos

Leadership

Regulatory compliance

Data analysis

Communication

Stakeholder management

Quality systems

Educación

Bachelor's degree in a scientific, engineering, quality, or related discipline

Professional certifications (ASQ, RAPS, Lean Six Sigma)

Descripción del empleo

Page Executive seeks a Director of Post Market Surveillance in Guadalajara to lead the global quality and compliance function for a medical technology leader. You will oversee a ~70-person team, manage post-market activities, regulatory interactions, CAPAs, and continuous improvement while ensuring patient safety and regulatory conformity across FDA, EU MDR, Health Canada and other authorities.

Fluent English required.