Job Description
**Main objective / purpose of the role:**
This role is to process MFDS product registrations w/ KGMP certification and post market surveillance of medical device in compliance with Regulatory & Corporate’s requirements.
**Critical success factors / key deliverables:**
+ Product Approval – to prepare tech file, submit and complete product registration to MFDS aligned with business plan in timely manner having with manager’s supervising.
+ Change management of product registrations to perform modification process following by Corporate’s Change Notification process & MFDS requirements
+ Processing new KGMP certification for MFDS product registration
+ Data management after product registration at internal Stryker system
+ Involve SKL’s QMS activities to maintain Stryker Korea’s QMS efficiently, which is complied with MDA(medical device act) observations, with ISO 13485 standards, and with Stryker standards. Those can be such as quality documentation...
This role is to process MFDS product registrations w/ KGMP certification and post market surveillance of medical device in compliance with Regulatory & Corporate’s requirements.
**Critical success factors / key deliverables:**
+ Product Approval – to prepare tech file, submit and complete product registration to MFDS aligned with business plan in timely manner having with manager’s supervising.
+ Change management of product registrations to perform modification process following by Corporate’s Change Notification process & MFDS requirements
+ Processing new KGMP certification for MFDS product registration
+ Data management after product registration at internal Stryker system
+ Involve SKL’s QMS activities to maintain Stryker Korea’s QMS efficiently, which is complied with MDA(medical device act) observations, with ISO 13485 standards, and with Stryker standards. Those can be such as quality documentation...
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