Responsibilities:
• Coordinate internal resources and third parties/vendors for the flawless execution of projects. It encompasses of in-house developed product, OEM product and product localization.
• Ensure that all projects are delivered on-time, within scope and within budget.
• Developing project scopes and objectives, involving all relevant stakeholders and ensuring technical feasibility.
• Ensure resource availability and allocation.
• Develop a detailed project plan to track progress.
• Use appropriate verification techniques to manage changes in project scope, schedule and costs.
• Measure project performance using appropriate systems, tools and techniques.
• Report and escalate to management as needed.
• Manage the relationship with the client and all stakeholders.
• Perform risk management to minimize project risks.
• Establish and maintain relationships with third parties/vendors.
• Create and maintain comprehensive project documentation.
• Demonstrate good project management culture to global Team.

Job Requirements:
• Minimum bachelor’s degree in any field, preferably in Biomedical Engineering.
• Minimum 5 years of experience in medical devices.
• PMP certification will be preferred.
• Good knowledge in ISO 9001, ISO 13485, ISO 14971, IEC62304 requirements.
• Understanding of cGMP/QSR and FDA, MDSAP, EU IVDR and EU MDR, China NMPA device/drug/biologics regulations.
• Experience in developing and making formal presentations.
• Excellent Communication skills.
• Familiarity with product/technology transfer and product management to support commercialization.
• Experience and knowledge in operations will be preferred.
• Strong team leadership and staff development skills.
• Occasional travel to R&D and manufacturing sites.

其他信息
语言要求：英语、普通话