- Single contributor
- Reports to Head of RA/QA APAC
- Located in Gangnam, South Korea
Responsible for managing all RA, QA and Reimbursement matter including product registration, medical devices national insurance classification & review, reimbursement application, and monitoring of healthcare policies. Understands the compliance requirements of regulatory affairs affecting company operations and products and manages document submission for new product registration or changes of existing licenses.
Responsible for managing an effective quality assurance system and ensuring compliance with regulatory requirements and ISO standards. Report the performance of quality management status to government authorities and Company management as required properly.
Regulatory Affairs (80%)
- Manages the process for registering and obtaining regulatory approvals for new and changed products with sufficient lead time for market introduction. Ensures all regulatory compliance, submissions and approvals are met
- Collaborate and establish robust information management systems / repository for Regulatory Affairs Department ensuring accuracy and completeness as well as document security
- Develop, implement and maintain regulatory strategies and regulatory submission plans in order to meet project milestones
- Prepare, update and maintain technical files / submission dossiers are per applicable SOPs, and liaise with the relevant department as required
- Collaborates cross-functionally with other departments, other subsidiary, and external resources including regulatory references to completion of regulatory filings. Corporate liaison between Arthrex Korea and all regulatory bodies
- Collaborate with Product Marketing team to explore the reimbursement opportunities and develop strategy to improve reimbursement environment
- Monitors and responds to government communication and potential changes of healthcare policies
- Support internal and external audits as required
- Contribute to the review and improvement of regulatory processes
Quality Assurance (20%)
- Support to Arthrex Korea Quality system and associated recording forms according to Compliance with a Medical Device Import Trader of MFDS
- Support internal quality audits, issuance, distribution and maintenance of training process related to quality
- Review and approve product labelling, literature, etc
- Serves as on-site quality management representative and liaison for contact with regulatory officials on quality issues
- Responsible for quality systems documentations and quality approval process including maintenance of accurate and complete records and files
- Partner with other key stakeholders to prepare and drive SOPs
- Bachelor’s Degree required, preferably in a Science or Engineering discipline.
- Training in technical aspects of regulatory affairs. 7+ years direct experience in Regulatory Affairs in a medical device company required. Orthopedics preferred.
- Strong interpersonal, oral and written communication skills required.
- High degree of understanding of regulatory requirements, scientific methods, and engineering fundamentals
- Ability to work in fast paced environment and handle multiple tasks and requests
- Has gained comprehension of orthopedic technical/engineering/medical terminology, or can reference literature for understanding
Reg No. R1109555
EBC Connect Pte Ltd
Licence no. 17C8975