[애보트메디칼코리아] RA Specialist

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