Director, Post Market Surveillance

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

• Lead a 70-person PMS team driving quality, compliance, and patient safety.
• Partner with global leaders and regulators to shape quality strategy.

About Our Client

Our client is a global leader in the medical technology industry, dedicated to improving patient outcomes through innovative healthcare solutions. With a strong commitment to quality, compliance, and continuous improvement, the company operates within a highly regulated environment and serves healthcare professionals and patients across multiple international markets.

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 global 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.

The Successful Applicant

A successful Director, Post Market Surveillance should have:

• Extensive experience in post-market surveillance or a related field within the life science industry.
• Strong knowledge of regulatory requirements and compliance standards.
• Proven ability to analyze and interpret complex data effectively.
• Leadership skills to manage and guide a specialized team.
• Excellent communication and presentation abilities for stakeholder engagement.

A background in a relevant scientific or technical field.Bachelor's degree in a scientific, engineering, quality, or related discipline.

Minimum of 12 years of experience within the medical device or life sciences industry, including at least 8 years in people leadership roles.

Strong expertise in Post Market Surveillance, complaint handling, vigilance reporting, adverse event management, and regulatory compliance.

Proven experience managing regulatory authority interactions, audits, inspections, and compliance-related activities.

Demonstrated ability to lead large teams through managers and supervisors in a global matrix environment.

Deep knowledge of medical device regulations and standards, including FDA Quality System Regulations, ISO 13485, ISO 14971, EU MDR, and related global frameworks.

Strong analytical, problem-solving, and decision-making skills with experience utilizing metrics, trends, and statistical analysis.

Excellent communication and stakeholder management abilities, with fluency in English.

Experience leading process improvement initiatives, CAPAs, and quality system enhancements.

• Professional certifications such as ASQ, RAPS, Lean Six Sigma, or equivalent are highly desirable.

What’s on Offer

Opportunity to lead a critical global quality and compliance function within a highly respected medical technology organization.

Significant people leadership responsibility with visibility to senior executives and global stakeholders.

Exposure to complex regulatory environments and international operations.

Ability to influence business performance, patient safety, and organizational strategy.

Competitive executive compensation package, including performance-based incentives and comprehensive benefits.

Long-term career growth within a global healthcare and medical device leader.