02 oct
|
Page Executive
|
Jalisco
02 oct
Page Executive
Jalisco
Lead a 70-person PMS team driving quality, compliance, and patient safety.
Partner with general leaders and regulators to shape quality strategy.
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.
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.
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.
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.
A successful Director, Post Market Surveillance should have:
Extensive experience in post-market surveillance or a related field within the life science industry.
Proven ability to analyze and interpret complex data effectively.
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 compli
📌 Head of Market Surveillance (Jalisco)
🏢 Page Executive
📍 Jalisco