Ensure compliance with MFDS requirements, including post-market surveillance, labeling, importer duties, QMS maintenance, and proper product release to customers.

Manage the QA team in performing post-market activities such as product complaints, field actions, and adverse event reporting, ensuring compliance with standards.

Responsible for maintaining ISO 13485 certification for Stryker Korea.

Serve as the key auditee during internal or external quality audits, ensuring successful outcomes.

Lead quality activities, including internal audits, supplier audits, CAPA, customer surveys, validation, and Quality Management Review meetings. Ensure proper maintenance of quality documents and records.

Oversee the quality management system of 3PL to meet internal and external requirements, including product labeling, storage, and

Lead the marketing team and develop the marketing strategy for the Diagnostic Solutions business unit.

Oversee monthly, quarterly, and yearly business forecasts.

Manage various marketing activities, including presentations, market research, KOL (Key Opinion Leader) support, and organizing congresses and exhibitions.

Analyze market trends, customer needs, and competitor activity to identify opportunities and guide product strategy.

Build and maintain strong relationships with Key Thought Leaders (KTL).

• Develop and implement key account business strategies and the company's overall mission (4i Value).
• Contribute market insights and perspectives to new regeneration project teams.
• Support Practical Process Improvement (PPI) projects to drive profitable growth through continuous improvement.
• Collaborate with internal and external stakeholders to adapt to organizational needs.
• Provide decision-making training for Life Science Group (LSG) commercial leaders.
• Create processes for understanding business requirements, designing analytics, and delivering insights.
• Identify and implement effective business intelligence tools (e.g., Power BI).