Johnson & Johnson Careers
[Medical Devices] Regulatory Affairs specialist
Requisition ID: 00001DXS
- Coordinates, compiles, and submits new devices applications, abbreviated new applications and investigational new devices applications to the regulatory agencies.
- Ensures compliance with regulatory agency regulations and interpretations.
- Prepares responses to regulatory agencies' questions and other correspondence.
- Organizes and maintains reporting schedules for new devices application and investigational new drug applications.
- Assists with preparing necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides.
- Provides solutions to a variety of problems of moderate scope of complexity.
- Conducts searches of existing files for requested information. Maintains and archives all regulatory documentation.
Johnson & Johnson Medical Taiwan Ltd. (8582)