RA Specialist (Temporary contract)

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.

Essential duties & responsibilities: (detailed description)

• Review, track and manage Change Notifications and take necessary action
• Data management including UDI after product registration at internal Stryker system
• Support and execute on the compilation of submission dossiers working with design divisions and tracking till registration is complete
• Processing new and renewal of KGMP certification for MFDS product registration and maintenance 
• 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
• Participate in various RA/QA projects internally and externally
• Do every work in compliance with regulatory requirements and Stryker corporate requirements.

Education & special trainings:

• BA in science, engineering, medical, law, etc.
• Better if fluent in English

Qualifications & experience:

• Min 1 yr of RA experience in healthcare industry preferred
• Better to have relevant experience of Government officials

Physical & mental requirements:

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