Job Description

Work Flexibility: Hybrid

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 c...

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