• Ensure compliance with FDA, CE, ISO 13485, and other regulatory standards for Class II and III medical devices.
• Prepare and submit regulatory documents for product registrations and approvals across international markets.
• Monitor and interpret regulatory changes, ensuring that products maintain ongoing compliance.
• Conduct internal regulatory audits to assess adherence to Quality Management System (QMS) and regulatory requirements.
• Collaborate with cross-functional teams (e.g., Product Development, Quality Assurance) to ensure regulatory requirements are met throughout the product lifecycle.
• Provide regulatory training and guidance to staff and stakeholders, ensuring awareness of relevant regulations.

• To direct, coordinate, impel and supervise the correct functioning of the different areas of the factory to achieve the production of manufactured products in the factories under the control of the group starting from raw materials, in accordance with the production plans and industrial policies, that satisfy the requirements of domestic consumption and the commercial area are implemented in time, method, quality and marked costs.

• 定期評估業務運營狀況，提出改進建議。
• 負責醫療設備、耗材及其他相關物品的採購。
• 建立供應商關係，進行議價以降低成本，提高效益
• 出色的溝通協調能力，能與不同部門有效合作。

1. Project management for server/storage products

2. Lead project team member to deliver the product in time with good quality and in scope.

3. Work as the coordinator among engineering, manufacturing, and customers.

4. Leading PM team to deliver a solution to the customer using the appropriate business measurements for managing all project planning and resources allocations.

• Strategic and Marketing Plan: Develop product positioning and strategies, followed by the execution of annual marketing plans
• Data Management and Training: Collect, compile, and analyze product data, and conduct related educational training sessions.
• Business Development: Identify and develop potential vaccine customers in non-traditional markets (beyond hospitals and clinics).
• Inventory Management: Execute sales forecasts and coordinate production for assigned products to ensure optimal inventory management.
• Public Tender Management: Oversee the execution of public tender projects.

• 擔任客戶、研發及生產間溝通的橋樑。
• 收集和分析產品需求，制定產品需求說明書以及規格。
• 制定產品開發計劃，包括產品開發進度、預算和資源等。
• 監督產品開發進度，設計符合市場需求並通過產品規範(如: ISO13485)。
• 協調產品開發過程中各部門和人員的工作，確保產品開發順利進行。
• 負責產品測試和驗收，確保產品質量符合要求。
• 收集客戶反饋，並提出產品改進建議。
• 協助客戶產品開發專案管理。
• 主管交辦事項。

1.Planning and Defining Scope.

2.Developing, Estimating and Management Schedules with Budget

3.Managing Risks and Issues

4.Monitoring and Reporting Progress

5.Stakeholder Communication and Management

6.Controlling Quality, Managing Documentation

7.Activity and Resource Planning and Sequencing

8.Scope and Plan Scope Change Management

9.Team Leadership, Business Partnering

10.Improving Process and Public Affairs

1. 負責電子商務專案相關業務推動及改善 (如:EDI 系統,訂單管理系統及數據平台應用)

2.Track and measure the impact of eCommerce initiatives on various KPIs, including traffic, engagements and conversions

1.負責工廠對外與客戶溝通的橋梁, 並滿足客戶對產品生產及出貨的需求&協調客戶工廠稽核、參訪事項安排。

2.產品專案管理，能與工廠與客戶協作。

3..英文簡報製作與簡報能力，能與客戶應對順暢。