高级测试经理--某500强欧洲医疗企业亚太研发中心

Key points:

  • Manage and develop the local test center including verification, testing, reliability engineering, test automation,

  • Build a network of local test service providers to react timely to project needs

  • Contribute to regulatory standard committees (CFDA, ISO, ...)

  • Work with RA lead for China (in different organization) on new product registrations, product changes and license renewals: Regulatory strategy, regulatory requirements, type test, technical dossier preparation

  • Lead for type test: Responsible for overseeing type test in new product registration (interface to CFDA test center)

  • Build relationship with authorities, e.g. consult on test methodologies

Required qualification:

  • At least 10 years of experience in medical device testing in an international company

  • Expert knowledge in CFDA regulatory field

  • Experience with CE and FDA regulatory field