J&J Family of Companies [Medical Devices] Regulatory Affairs specialist in Taipei, Taiwan

  • 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.

Qualifications

see above

Primary Location

Taiwan-Taipei-Taipei-

Organization

Johnson & Johnson Medical Taiwan Ltd. (8582)

Job Function

Regulatory Affairs

Requisition ID

00001DXS