Job Description

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Technical Specialist & Scheme Manager – General Devices

China – homebased

About the role

Our Regulatory Services team are looking for a Technical Specialist & Scheme Manager who will provide specialist regulatory, operational and strategic support as a scheme manager, products specialist to the business in the delivery of CE medical device marking schemes.

Responsibilities

  • Review and evaluate medical device technical and clinical documentation in your areas of competence to assess compliance with MDD 93/42/EEC, MDR 2017/745 and UK MDR 2002 schemes.
  • Manage certification activities for a portfolio of medical device manufacturers, including determination of auditing requirements and making recommendations for the issue and maintenance of CE certifications.
  • Closely work with Technical Team Managers to de...

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