Principal RA engineer

2 months ago

Shanghai, China Danaher Corporation Full time

Registration

  • 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. o Coaching colleagues general priciples of NMPA regulation, FDA regulation, EU directives, etc. other tasks assigned by direct line manager.

RA & DQA

  • Be responsible on planning design control strategy at the project planning phase, including lead discussion with project team, provide suggestions on process control, etc.

  • Be responsible for controlling the design quality during the design and development phase, including review DHF, lead design review with the support from project manager, etc.

  • Act as a major representative RAQA role in project team wheel, lead the RAQA activities in the project.

  • 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.

  • Coaching all risk management related functions and orienting new colleagues general risk management principles.

  • Support design and development related functions on establishing process control for compliance with regulatory requirement, including NMPA, FDA, EU, etc.

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.

At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.

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