YI HSUAN LI
RA Specialist
Taipei
Summary
Results-driven regulatory affairs professional with experience in executing medical device licensing applications and maintaining compliance. Skilled in documentation management and analytical thinking, contributing to informed strategic decisions and enhanced project workflows.
Overview
1
1
Language
2
2
years of professional experience
Work History
RA Specialist
Stryker
Taipei City, Taiwan
03.2025 - Current
- Executed medical device licensing applications, covering new product approvals, renewals, and amendments, with consistent on‑time delivery.
- QSD renewal and application.
- Managed product documentation to ensure compliance with regulatory standards.
- Maintained the internal license database systems.
- Labeling change for CoO.
- Collaborated with cross-functional teams to streamline project workflows.
- Analyzed market trends to support strategic decision-making processes.
- Collaborated with the company's operations team to process orders, such as overseas shipments and delivery schedules.
Sales and Executive Assistant
Dingxin Industrial Co., Ltd.
Taipei, Taiwan
03.2024 - 03.2025
- Coordinated executive schedules, optimizing time management and meeting efficiency.
- Handled customer orders received via email and phone, ensuring accurate processing and timely delivery.
- Created and managed sales orders through ERP system to coordinate shipments to clients.
- Assisted sales representatives with product order management and provided customer feedback to support business decisions.
- Conducted regular inventory checks to maintain stock accuracy and availability.
Education
Bachelor of Science - Public Health
Chung Shan Medical University
Taichang, Taiwan 04.2001 -
Skills
Expert problem solving
Quality assurance
Management collaboration
Advanced communication
Analytical thinking
Regulatory compliance
Timeline
RA Specialist
Stryker
03.2025 - Current
Sales and Executive Assistant
Dingxin Industrial Co., Ltd.
03.2024 - 03.2025
Bachelor of Science - Public Health
Chung Shan Medical University
04.2001 -