02 oct
|
Page Executive
|
Centro
02 oct
Page Executive
Centro
- Lead a 70-person PMS team driving quality, compliance, and patient safety.
- Partner with general leaders and regulators to shape quality strategy.
About Our Client
Our client is a general 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 sci
📌 Director, Post Market Surveillance (Centro)
🏢 Page Executive
📍 Centro