Major Responsibilities

• Be responsible for medical device registration, class 1, class 2 and class 3 in NMPA.
• Be responsible for existing products renewal registration and change registration.
• Be responsible for supporting global RA team to complete new product registration and existing product renewal registration worldwide.
• Be responsible for leading site MDR/AE reporting and recall activities.
• Act as a major representative RAQA role in project team wheel, lead the RAQA activities in the project.
• Be responsible for leading regulatory activities during design and development phase.
• Support site QMS to ensure it fully compliance to medical device regulatory requirements.
• Be responsible for leading new product risk management activities during design and development phase.
• Be responsible for existing products risk management maintenance, evaluate the product risk in design changes, nonconforming, customer complaints, etc.
• Be responsible for leading risk management tasks from regulatory requirement, NMPA, FDA, etc.

Skills:

• Strong capability in medical device registration of Class 1, Class 2 and Class 3 in NMPA.
• Strong knowledge of composing NMPA registration files, and global registration files.
• Strong knowledge of regulatory requirements for medical device for the whole lifecycle.
• Strong capability in leading MDR/AE and Recall activities.
• Good knowledge of worldwide regulatory requirements, mainly for FDA and EU IVDR/MDR.
• Good knowledge of ISO13485, China GMP and FDA GMP.
• Strong capability in leading PSP (Problem Solving Process) and driving good solutions.
• Good capability in risk management process for the product lifecycle, including design phase and post market phase.
• Good knowledge of risk management related GB standards, ISO standards, etc.
• Good knowledge of medical device regulatory requirements related to risk controls.
• Excellent English in verbal and written.

Competencies/Behaviours

• Good team collaboration
• Self-motivated
• Act initiatively and proactively.
• Sense of urgency to drive result and moving project forward.
• Good CFT communication skill. Explains difficult or sensitive information; works to build consensus.
• Good leading and coaching skill.
• Good integrity.

Education:

• Bachelor’s degree or above. Science and Engineering or equivalent education.

Experience:

• 5+ years above experience in medical device domestic registration, or 5+ years above experience related to manufacturing, or R&D quality assurance.
• Successfully accomplish more than one Class 2 or Class 3 medical device registration is preferred.
• Working experience in Medical Device manfacturing field is preferred.
• Good knowledge of FDA, EU IVDR/MDR registration is preferred.
• 2+ projects above experience in risk management field.
• Global collaboration experience is preferred.

Language: Native Chinese & Good English

At Danaher we bring together science, technology and operational capabilities to accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. Our global teams are pioneering what’s next across Life Sciences, Diagnostics, Biotechnology and beyond. For more information, visit www.danaher.com.

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