Senior RA Specialist

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, internal audit, training, participation in internal or external audits, etc.
• Collaborate with business franchise partner, Stryker Design division RAQA, and regulatory agencies and draw out the effective communications and resolutions on any issues that may arise on work
• Actively participate in MFDS or external meetings as a professional manner
• Participate in various RA projects internally and externally
• Do every work in compliance with regulatory requirements and Stryker corporate requirements

Knowledge / Skills / Attributes

Academic qualifications / degree & relevant prior experience:

Key strengths / personal attributes for the role:

• BA in science, engineering, medical, law, etc.
• Min 4yr of RA experience in healthcare industry
• Better to have relevant experience of Government officials
• Better if fluent in English

• Well-organized and logical thinking
• Passionate and a great sense of responsibility
• Committed to punctuality, discipline & detailed
• Professional communication skills
• Strategic and planning skills