Beckman Coulter Diagnostics seeks a Specialist in Commercial Quality and Regulatory Affairs to manage product registration, quality processes, and post-market vigilance across Mexico and LATAM countries. The role supports regulatory compliance, internal quality audits, and technical documentation for diagnostic devices.
Responsibilities
Review and maintain Quality Management System alignment with current sanitary regulations
Support warehouse GMP oversight through internal audits, sanitary agency audits, and supplier evaluations
Prepare technical dossiers for new product registration, license renewals, and post-market vigilance activities




Evaluate design changes against regulatory requirements and maintain legal document database for registrations
Provide technical documentation to sales channel partners for their regulatory submissions
Requirements
Bachelor's degree in pharmacy, biology, biomedical engineering, or chemistry
More than 2 years of quality assurance experience
Knowledge of Mexico and LATAM medical device regulations
Basic English proficiency for document review and integral communication
Familiarity with Quality Management Systems and GMP regulations
Cross-functional teamwork and communication skills

📌 Specialist, Commercial Quality And Regulatory Affairs (Xico)
🏢 Danaher
📍 Xico