Medical Device Post‑Market Investigator

Intuitive; Mexicali; Presencial; MXN 350.000 - 550.000; Jornada completa

Descripción de la vacante

Intuitive in Mexico is seeking a Regulatory Post Market Surveillance Specialist to investigate and manage medical device complaints, perform failure analysis, and ensure regulatory reporting compliance.

You will classify complaints, file MDR reports, escalate issues, and collaborate with Customer Service and hospitals to gather information required for investigations. This role emphasizes thorough documentation, backlog management, and continuous process improvement.

Formación

• Education in engineering or life science; English proficiency required: 85% (spoken and written).
• 2+ years of experience in medical device field with knowledge of complaint files and quality record documentation.
• Knowledge of regulatory reporting requirements for Medical Devices (US FDA, EU MDD, etc.).

Responsabilidades

• Investigate customer complaints and provide failure analysis letters.
• Classify complaints and escalate as needed.
• File MDR reports and escalate to PMI as required.
• Review lot documentation for anomalies related to product failures.
• Interface with Customer Service and hospitals to gather information for investigations.
• Create customer response letters and participate in training and process improvements.

Conocimientos

Strong communication

Independent worker

Cross-functional collaboration

Analytical skills

Organizational skills

Decision making

Educación

Engineering or life science degree

Descripción del empleo

Intuitive in Mexico is seeking a Regulatory Post Market Surveillance Specialist to investigate and manage medical device complaints, perform failure analysis, and ensure regulatory reporting compliance.

You will classify complaints, file MDR reports, escalate issues, and collaborate with Customer Service and hospitals to gather information required for investigations. This role emphasizes thorough documentation, backlog management, and continuous process improvement.