Responsable Sanitario de Dispositivos Médicos
Core
Ensure regulatory, sanitary, and quality compliance for medical devices through management of the quality management system, product release, and implementation of good manufacturing practices.
Role type
Senior Regulatory Quality Manager (Medical Devices)
Builds
Medical devices
Domain
Medical devices / Industrial gases
Required skills
Regulatory compliance (NOM-241-SSA1, ISO 13485), Quality Management System administration, Product release and rejection, Change control and CAPA management, Risk management, Adverse event and complaint handling, Internal and external audit coordination, Technical training and team leadership
Preferred skills
Experience in pharmaceutical or medical device manufacturing processes, Knowledge of biomedical and electronic equipment, Project management for continuous improvement
Technologies
Quality Management Systems, Regulatory databases
Responsibilities
Act as the official sanitary representative before regulatory authorities. Release or reject medical devices based on technical and regulatory specifications. Manage and maintain the Quality Management System for medical devices. Coordinate technovigilance activities, complaints, returns, product recalls, and adverse events. Attend internal, external, and regulatory audits. Manage permits, certifications, and regulatory documentation. Supervise maintenance, verification, and performance of medical devices. Lead continuous improvement, quality, and regulatory compliance projects.
Seniority
Senior, hands-on IC