Regulatory Health Authority Analyst — QA & Audit Lead

8283-EES S.A de C.V. Legal Entity; Ciudad Juárez; Presencial; MXN 700.000 - 1.050.000; Jornada completa

Descripción de la vacante

Johnson & Johnson in Juarez City seeks a Senior Health Authority Reporting Analyst to advance regulatory reporting and complaint management within a global health system.

You will demonstrate world-class customer support, maintain product knowledge, and lead MDR/MDV decisions, file MedWatch, and coordinate information with internal teams to ensure timely, compliant reporting across FDA/EU guidelines.

Formación

• Completed apprenticeship or bachelor's degree in a scientific/medical field.
• 2–4 years of related experience desirable.
• Knowledge of FDA, Medical Device Directives/Regulations, and ISO requirements.
• Knowledge of human anatomy and medical terminology.
• Strong written and verbal communication in English (B2).
• Ability to work in cross-functional teams and manage priorities.

Responsabilidades

• Demonstrate world-class customer support and maintain product knowledge.
• Assess and close complaint files per procedures and CQ expectations.
• Make regulatory reporting determinations for one or more business units.
• File MedWatch and MDV reports within required timelines.
• Lead and support audits and compliance reviews when needed.
• Coordinate information with internal sites to ensure timely investigations.
• Support onboarding and training of new associates.

Conocimientos

Written and verbal communication

Decision making

Cross-functional work

Independent work

Time management

Attention to detail

Audit management

Compliance awareness

Data analysis

Educación

Bachelor's degree in Scientific/Medical/Life Science/Health Science/Technical/Engineering

Descripción del empleo

Johnson & Johnson in Juarez City seeks a Senior Health Authority Reporting Analyst to advance regulatory reporting and complaint management within a global health system.

You will demonstrate world-class customer support, maintain product knowledge, and lead MDR/MDV decisions, file MedWatch, and coordinate information with internal teams to ensure timely, compliant reporting across FDA/EU guidelines.