About the Company
As a global medical device company originating from Japan, we pursue reliable quality and technology to contribute to healthcare in more than 160 countries and regions around the globe. We promise to walk alongside healthcare professionals to continue to make great contribution to society, now and into the future.
Summary of the Role
The Regulatory Affairs Specialist is mainly responsible for planning and executing activities for product registration/renewal in accordance with regulatory requirements to meet the company business objectives and bring safe and quality-guaranteed products to customers under moderate supervision of RA&QA Manager.
Key Responsibilities
1. Products Registration / Renewal
Prepare required documents for product registration/renewal/license to MFDS and obtain regulatory approvals on time to enable new products to be launched and maintained in market
Monitor registered products are maintained and updated in full compliance with all relevant legislation and SOPs
Implement regulatory strategy for product license renewal and maintenance
Communicate with manufacturers (Terumo internal, third party etc.) to gather documents needed for registration/renewal
Ensure documentation and record are archived and updated securely in accordance with all relevant legislation and SOPs
Follow up of mandatory requirements for registration for local certificates, importation of samples and local testing etc.
Follow up post-approval activities
Take charge in products for assigned projects
2. Reimbursement
Prepare required documents and manage processes for reimbursement price
Execute Pricing and Reimbursement strategy and plan and support for the assigned product
Drive competitor analysis, stakeholder research and financial modeling to support TKC’s market access strategies
Monitor and analysis of Pricing and Reimbursement policy changes
3. Quality Management System (QMS)
Maintain and support continuous improvement of the local Quality Management System in accordance with: Develop, review, and maintain quality procedures, work instructions, and quality records.
Support document control and training management processes.
Participate in Management Review activities and quality metric reporting.
Ensure quality records are maintained in accordance with applicable regulatory requirements.
4. Post-Market Surveillance (PMS) & Vigilance
Serve as the local QA lead for Post-Market Surveillance activities.
Review, investigate, and manage product complaints, adverse events, and safety-related issues.
Ensure timely reporting of: Coordinate complaint investigations with Global Quality, manufacturers, and Regulatory Affairs teams.
Monitor post-market data and identify quality trends, emerging risks, and potential safety signals.
Support implementation and effectiveness monitoring of field actions and corrective measures.
5. KGMP Compliance & Inspection Management
Coordinate KGMP certification maintenance activities and inspection readiness programs.
Act as the primary QA contact during: Collaborate with manufacturing sites and global quality teams to support KGMP compliance.
KGMP inspections MFDS audits Internal audits Corporate quality audits
Track audit findings and ensure timely implementation of corrective and preventive actions.
Maintain inspection readiness and support successful audit outcomes.
6. Others
Build and maintain close working relationships/communication with relevant regulatory authorities and relevant stakeholders to ensure smooth and timely operations of Regulatory affairs
Partnering with cross functional teams by providing preliminary regulatory guidance and support for strategic planning, design and development, and compliance activities
Provide Regulatory Affairs support and appropriate follow-up during internal and external inspections and audits
Participate in Developing and implementing regulatory strategies and operating plans
Have a proactive contribution to the…