Senior Health Authority Regulatory Reporting Lead

Johnson Johnson; Ciudad Juárez; Presencial; MXN 550.000 - 820.000; Jornada completa

Descripción de la vacante

Johnson & Johnson in Juarez City is seeking a Senior Health Authority Reporting Analyst to support regulatory reporting for multiple business units. You will assess, approve or reassess MDR/MDV decisions and manage complaint investigations within required timelines.

The role requires a completed degree (bachelor’s or apprenticeship), 2–4 years of related experience, knowledge of FDA and ISO requirements, strong English skills, and the ability to work cross-functionally.

Formación

• Bachelor's degree or apprenticeship in scientific, medical, life science, health science, technical or engineering field.
• 2–4 years of related experience desirable.
• Knowledge of FDA, Medical Device Directives, ISO requirements.

Responsabilidades

• Demonstrate world-class customer support and maintain knowledge of product areas.
• Assess, process, and close complaint files per procedures and CQ expectations.
• Make regulatory reporting determinations (MDR/MDV) for one or more units.
• File MedWatch and MDVs within required timelines as applicable.
• Coordinate information and follow up questions for investigations.
• Lead/ support audit and compliance reviews.
• Maintain understanding of quality system policies and procedures.
• Lead assigned projects toward business outcomes.

Conocimientos

English proficiency

Regulatory knowledge

Communication skills

Cross-functional collaboration

Attention to detail

Educación

Bachelor's degree or apprenticeship

Descripción del empleo

Johnson & Johnson in Juarez City is seeking a Senior Health Authority Reporting Analyst to support regulatory reporting for multiple business units. You will assess, approve or reassess MDR/MDV decisions and manage complaint investigations within required timelines.

The role requires a completed degree (bachelor’s or apprenticeship), 2–4 years of related experience, knowledge of FDA and ISO requirements, strong English skills, and the ability to work cross-functionally.