Our client is a global medical device company and leader in new product development and medical education in orthopedics. They have pioneered the field of arthroscopy and develops more than 1,000 innovative products and procedures each year. PURPOSE 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.
JOB RESPONSIBILITIES 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 Korea office 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 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