LATAM Commercial Quality & Regulatory Specialist

Danaher Corporation; Ciudad de México; Presencial; MXN 450.000 - 600.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Bonus eligibility

Health insurance

Pension plan

Paid time off

Descripción de la vacante

Beckman Coulter Diagnostics, a Danaher operating company, seeks a Specialist in Commercial Quality & Regulatory Affairs to support regulatory submissions, registrations, and post-market vigilance across LATAM from Mexico. The role is on-site and collaborates with sales, operations, and marketing to ensure regulatory compliance.

Ideal candidates have a degree in pharmacy, biology, biomedical engineering or chemistry and 2+ years in QA/regulatory roles, with knowledge of LATAM regulations and

Formación

• Bachelor's degree in pharmacy, biology, biomedical engineering or chemistry.
• 2+ years experience in quality assurance or regulatory affairs is preferred.
• Knowledge of Mexico and LATAM medical device regulations.
• English language (basic) to read documents and communicate with global teams.
• Experience with Quality Management Systems and GMP regulations.

Responsabilidades

• Review and ensure the Quality Management System aligns with current sanitary regulations.
• Support quality audits with internal and external stakeholders (distributors, suppliers, regulatory bodies).
• Prepare technical dossiers to support product registrations and license renewals; assist with post-market vigilance.
• Evaluate design changes against regulatory requirements for license modifications; organize legal document databases for tenders.
• Provide technical documentation to support regulatory submissions for Sales Channel Partners.

Conocimientos

Cross-functional teamwork

Analytical skills

Problem solving

Communication skills

Educación

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

Descripción del empleo

Beckman Coulter Diagnostics, a Danaher operating company, seeks a Specialist in Commercial Quality & Regulatory Affairs to support regulatory submissions, registrations, and post-market vigilance across LATAM from Mexico. The role is on-site and collaborates with sales, operations, and marketing to ensure regulatory compliance.

Ideal candidates have a degree in pharmacy, biology, biomedical engineering or chemistry and 2+ years in QA/regulatory roles, with knowledge of LATAM regulations and