글로벌 의료기 RA 대리과장

▣ 담당업무
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.




▣ 자격요건
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