Senior Regulatory Reporting & Quality Analyst

Johnson & Johnson Innovation; Ciudad Juárez; Presencial; MXN 420.000 - 640.000; Jornada completa

Descripción de la vacante

Johnson & Johnson in Juarez City seeks a Senior Health Authority Reporting Analyst to manage regulatory reporting for health authorities and complaint investigations. The role supports MDR/MDV decisions, FDA/EU guidelines, and audits, ensuring compliance across business units and international sites.

You will lead complaint investigations, coordinate with cross-functional teams, and maintain regulatory reporting tables.

Formación

• Completed apprenticeship or bachelor's degree in Scientific/Medical/ Life Science/ Health Science/ Technical/ Engineering field or equivalent.
• 2–4 years related experience desirable.
• Knowledge of FDA, Medical Device Directives/Regulation & ISO requirements.
• Fluent English with at least B2 written level.
• Ability to work in cross-functional/matrix environment and independently.
• Strong attention to detail and time management.

Responsabilidades

• Provide world-class customer support for relevant products and services.
• Assess, process and close complaint files per CQ expectations and procedures.
• Make regulatory reporting determinations for one or more Business Units (MDR/MDV).
• File Medwatch and MDV reports within required timelines per guidelines.
• Lead/ support audit and compliance reviews as needed.
• Maintain understanding of applicable quality system policies and procedures.
• Lead onboarding training for new associates and drive process improvements.

Conocimientos

Communication skills

English fluency

Cross-functional teamwork

Decision making

Time management

Independence

Continuous improvement

Educación

Bachelor's degree or equivalent

Descripción del empleo

Johnson & Johnson in Juarez City seeks a Senior Health Authority Reporting Analyst to manage regulatory reporting for health authorities and complaint investigations. The role supports MDR/MDV decisions, FDA/EU guidelines, and audits, ensuring compliance across business units and international sites.

You will lead complaint investigations, coordinate with cross-functional teams, and maintain regulatory reporting tables.