Regulatory Health Authority Reporting Specialist

J&J Family of Companies; Ciudad Juárez; Presencial; MXN 600.000 - 900.000; Jornada completa

Descripción de la vacante

Johnson & Johnson in Ciudad Juárez is seeking a Senior Health Authority Reporting Analyst to support regulatory reporting and complaint management across global operations.

You will assess files, file MedWatch and MDVs within required timelines, and manage health authority requests in line with FDA and EU guidelines. The role involves cross-functional collaboration and ongoing process improvement.

Formación

• Fluent English speaker with written English to B2 standard.
• Strong written and verbal communication skills.
• Ability to work in a cross-functional and matrix environment.
• Ability to handle multiple priorities and changes in priorities.

Responsabilidades

• Demonstrate world-class customer support and maintain knowledge of relevant Operating Company’s products and services.
• Assess, process, and close complaint files within scope of internally and externally manufactured products in accordance with complaint handling procedures and CQ expectations.
• Make regulatory reporting determinations on applicable files for one or more Business Units. Execute file reviews and manage complaint file activities.
• File Medwatch report forms within required timelines as applicable.
• Create and/or forward additional information to support complaint investigations and ensure timely execution of complaint file management.
• Lead/ support audit and compliance review processes as needed.
• Maintain understanding of current Customer Quality and other independent quality system policies and procedures.

Descripción del empleo

Johnson & Johnson in Ciudad Juárez is seeking a Senior Health Authority Reporting Analyst to support regulatory reporting and complaint management across global operations.

You will assess files, file MedWatch and MDVs within required timelines, and manage health authority requests in line with FDA and EU guidelines. The role involves cross-functional collaboration and ongoing process improvement.