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