LATAM Regulatory & Quality Affairs Specialist

Beckman Coulter Diagnostics; México; On-site; MXN 700,000 - 900,000; Full time

Job summary

Beckman Coulter Diagnostics, a Danaher operating company, is seeking a Specialist, Commercial Quality & Regulatory Affairs to support regulatory processes across LATAM from Mexico. This on-site role collaborates with Sales, Operations and Marketing to ensure compliance and timely registrations.

You will manage product registrations, post-market vigilance, and quality documentation, working under the Senior Manager, Commercial Quality Assurance LATAM, in a dynamic, cross-functional team across

Qualifications

• Bachelor’s degree in pharmacy, biology, biomedical engineering or chemistry.
• Experience in quality assurance; regulatory affairs experience is a plus.
• Knowledge of Mexico and LATAM medical device regulations and GMP.

Responsibilities

• Review and ensure Quality Management System compliance with sanitary regulations.
• Support GMP oversight and internal/external quality audits.
• Prepare technical dossiers to support registrations for new products and renewals.
• Evaluate regulatory implications of design changes and maintain legal document databases for tenders and regulatory processes.
• Support Sales Channel Partners with regulatory documentation for submissions.

Skills

Cross-functional teamwork

Analytical skills

Problem-solving

Basic English

Education

Bachelor’s degree in pharmacy, biology, biomedical engineering or chemistry

Tools

GMP knowledge

Quality Management Systems

Job description

Beckman Coulter Diagnostics, a Danaher operating company, is seeking a Specialist, Commercial Quality & Regulatory Affairs to support regulatory processes across LATAM from Mexico. This on-site role collaborates with Sales, Operations and Marketing to ensure compliance and timely registrations.

You will manage product registrations, post-market vigilance, and quality documentation, working under the Senior Manager, Commercial Quality Assurance LATAM, in a dynamic, cross-functional team across