RA Specialist

Abbott

Abbott

Seoul, South Korea
Posted on Tuesday, July 9, 2024

ABOUT ABBOTT:
Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.

JOB PURPOSE AND SCOPE:

  • Responsible for the coordination and preparation of document packages for regulatory submissions.
  • Monitors and improves tracking/control systems.
  • Keeps abreast of regulatory procedures and changes.
  • May direct interaction with regulatory agencies on defined matters.
  • Ensures rapid and timely approval on medical devices and continued approved status of marketed medical devices.
  • Ensures compliance with regulations and interpretations

CORE JOB RESPONSIBILITIES:

  • Compiles all materials required in submissions and license renewal.
  • Coordinates and maintains reporting schedules for product licensing application notices.
  • Interacts with regulatory agency personnel in order to expedite approval of pending applications.
  • Compliance Work, procedures, employee trainings, promo materials, registration/approval etc.

MINIMUM SKILLS REQUIRED:

  • Understanding of Regulatory Affairs in Medical Device
  • Organized with a high attention to detail
  • Skill to conduct multiple tasks at the same time
  • Communication skills
  • Customer responsiveness to needs of commercial operations
  • Strong quality compliance ethos
  • Excellent spoken and written of English and local language

EXPERIENCE REQUIRED:

  • Bachelor Degree - 3 to 8 years of relevant experience
  • Experience gained in multinational medical device companies will be an advantage