Regulatory Affairs Specialist

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 overall QA & RA department growth
• Assist in SOP development, review, and initiation
• Cooperate with QA team for the development, establishment, and implementation of all aspects of the quality assurance and quality control
• Participate in internal & external meetings 
• Stay abreast of regulatory procedures and changes in regulatory climate
• Actively participate in various QA & RA projects

Functional / Technical Skills

• 5~10+ years of industry experience
• Strong communication and negotiation skills
• In-depth knowledge of Korean medical device act and regulations
• Project Management
• Time-management skills
• Quality systems and compliance
• Product technical knowledge

Education & Experience

• Bachelors’ degree in any related field of study
• Previous experience in a Regulatory Affairs/Quality Assurance related position
• Quality Assurance knowledge is advantageous
• Excellent verbal and written communications skills
• Preferably someone from medical device industry
• Advanced level of IT with Microsoft office skills
• Fluent in English and local national language (written and spoken)
• Proactive team player with a strong drive to create a positive work environment and bring the best result

Note to External Recruitment Agencies:

Terumo does not recognize candidate submissions from any recruitment agencies and will not be responsible for payment of any recruitment fees due to the hiring of candidates whose resumes were submitted to Terumo employees or offices without the recruiting team's acknowledgement.