Johnson & Johnson Careers

[Medical Devices] Regulatory Affairs Specialist

Taipei, Taiwan
Regulatory Affairs


Job Description

Requisition ID: 1805703820W

  • 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
1805703820W