Work Flexibility: Hybrid
Essential duties & responsibilities:
- Identifies information sources and resources for local, regional, and global regulations
- 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 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 partners, 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:
- Bachelor’s degree in science, engineering, medical, law, etc.
- Better if fluent in English
Qualifications & experience:
- Regulatory Affairs experience in the healthcare industry preferred (minimum 1 year desirable, not mandatory)
- Better to have relevant experience of Government officials
Travel Percentage: 0%