Senior Health Authority Reporting Analyst
Johnson & Johnson · Chihuahua, Mexico
RegulatoryFull-timeCompany career page
The apply link worked recently (not employer-confirmed).
Role summary
Senior Health Authority Reporting Analyst position at Johnson & Johnson in Ciudad Juarez, Mexico, focused on regulatory compliance and complaint management for medical devices. The role involves processing health authority requests, making regulatory reporting determinations, and managing complaint files across multiple business units in accordance with FDA and EU regulations.
What they're looking for
- Bachelor's degree in scientific, medical, life science, health science, technical, or engineering field
- 2–4 years of related quality or regulatory experience
- Knowledge of FDA regulations, Medical Device Directives, and ISO requirements
- Fluent English speaker at B2 written standard; strong written and verbal communication
- Knowledge of human anatomy, medical terminology, and relevant business unit products
- Strong decision-making and problem-solving abilities with limited information
- Ability to work independently and manage multiple priorities in matrix environments
What you'll be doing
- Assess, process, and close complaint files for internally and externally manufactured products
- Make regulatory reporting determinations and execute MDR/MDV decisions for applicable business units
- File Medwatch reports and MDVs according to EEA, Switzerland, Turkey, and other regulatory timelines
- Manage health authority requests, including standard and non-standard inquiries, with appropriate justifications
- Lead onboarding and training of new associates on product-specific and quality system procedures
Privacy & handoff
This role links to Johnson & Johnson's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.