RA Specialist

Korea - Seoulmid

Logistics & Supply ChainRoad Specialist

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Key Responsibilities

대치동 & 역삼동 JOB PURPOSE AND SCOPE: Responsible for the coordination and preparation of document packages for re

Technical Tools

Logistics & Supply ChainRoad Specialist

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

~1 min read

→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.

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
Bachelor degree at Science, Life-Science, Life- Engineering, etc. will be an advantage.
Skill to interpret medical devices regulations, pharma-regulations, etc

Bachelor Degree : 2 to 4 years of relevant experience (general electronic science/Biology/Biomed degree)
Experience gained in multinational medical device companies will be beneficial

N/A

In specific locations, the pay range may vary from the range posted.

Regulatory Operations

MD Medical Devices

Korea > Seoul : SamTan Building, 421 Youngdong-daero, Gangnam-gu

Standard

Yes, 5 % of the Time

Not Applicable