Johnson & Johnson Careers

[Medical Devices] Regulatory Affairs specialist

Taipei, Taiwan
Regulatory Affairs

Job Description

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.

see above
Primary Location
Johnson & Johnson Medical Taiwan Ltd. (8582)
Job Function
Regulatory Affairs
Requisition ID