Global Post-Market Surveillance Analyst (Bilingual)

Fresenius Medical Care; Reynosa; Presencial; MXN 350.000 - 480.000; Jornada completa

Descripción de la vacante

Fresenius Medical Care in Reynosa, Mexico seeks a Post Market Surveillance Specialist to review, document, and process product complaints in compliance with regulations and company procedures. You will collaborate with Quality Engineering, Pharmacovigilance, Customer Service, and Manufacturing to support investigations and reporting.

The role requires bilingual English and Spanish communication, strong analytical skills, and experience with quality systems and data analysis.

Formación

• Bachelor’s Degree preferred in healthcare, life sciences, engineering, or related field.
• Experience with complaint handling, quality systems, or medical device regulations preferred.
• Strong analytic, communication, and customer service skills.
• Proficiency in Microsoft Office applications, particularly Excel.
• Experience with complaint management systems and data analysis tools is a plus.
• Familiarity with medical terminology preferred.
• Fluent English and Spanish (bilingual required).

Responsabilidades

• Receive, review, and document product complaints and inquiries using GDP.
• Ensure complaints from multiple sources are accurately entered into the Complaint Management System.
• Collect additional information, product samples, and equipment as needed to support investigations.
• Support complaint coding, investigation follow-up, trending analysis, and complaint file closure.
• Partner with Quality Engineering, Manufacturing, and Pharmacovigilance teams on product investigations and reportable events.
• Ensure compliance with regulatory requirements, company policies, and quality system procedures.
• Maintain high data accuracy and documentation standards.

Conocimientos

Analytical skills

Communication skills

Customer service

Bilingual English/Spanish

Educación

Bachelor's degree in Healthcare/Life Sciences/Engineering

Herramientas

Complaint Management System

Descripción del empleo

Fresenius Medical Care in Reynosa, Mexico seeks a Post Market Surveillance Specialist to review, document, and process product complaints in compliance with regulations and company procedures. You will collaborate with Quality Engineering, Pharmacovigilance, Customer Service, and Manufacturing to support investigations and reporting.

The role requires bilingual English and Spanish communication, strong analytical skills, and experience with quality systems and data analysis.