Senior Health Authority Reporting Analyst (MedTech)

Location: Ciudad Juarez, Chihuahua, Mexico; onsite in Juarez City

Company

Johnson & Johnson MedTech develops innovative, less invasive, and personalized healthcare and medical device solutions.

What you will do

• Assess, process, and close complaint files for internally and externally manufactured products.
• Make and reassess regulatory reporting determinations, including MDR and MDV decisions.
• File MedWatch and MDV reports within required timelines under applicable FDA, EU, EEA, Switzerland, Turkey, and other country requirements.
• Manage Health Authority requests, additional information requests, non-reporting justifications, and complaint investigation activities.
• Support audits, compliance reviews, escalation processes, and maintenance of reporting lists and regulatory tables.
• Lead assigned projects, onboarding training, and collaboration with internal and external stakeholders.

Requirements

• Completed apprenticeship, bachelor's degree, or equivalent experience; a scientific, medical, life science, health science, technical, or engineering background is preferred.
• 2–4 years of related experience is desirable.
• Knowledge of quality requirements, FDA regulations, medical device directives and regulations, and ISO requirements.
• Knowledge of human anatomy, medical terminology, and applicable medical device products.
• Fluent spoken English and written English at B2 level required.
• Strong decision-making, communication, attention to detail, independent working, time management, and prioritization skills.

Nice to have

• Audit management and compliance management experience.
• Experience with continuous improvement, data analysis, internal controls, quality control, and quality management systems.
• Experience with issue escalation, coaching, problem solving, and quality standards.

Culture & Benefits

• Inclusive work environment that respects diversity, dignity, and individual contributions.
• Cross-functional and matrix-based collaboration.
• Opportunities to lead projects, training, compliance reviews, and process improvements.
• Work governed by company health, safety, environmental, quality, and regulatory standards.