CSA Group

Lead Assessor

CSA Group(1 day ago)

Shanghai, ChinaOnsiteFull TimeSenior$97,688 - $133,683 (estimated)Quality Assurance / Regulatory
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About this role

CSA Group is seeking a qualified professional to conduct and lead audits of medical device and IVD manufacturers, assessing compliance with safety, performance, and regulatory standards. The role involves evaluating technical files and clinical data, collaborating with teams, and ensuring adherence to certification requirements. It plays a key part in certifying products that meet strict international safety and quality standards.

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Required Skills

  • Audit
  • Medical Devices
  • Regulations
  • ISO 13485
  • Clinical Evaluation
  • Technical Files
  • Risk Management
  • Quality Management
  • Regulatory Compliance
  • Certification

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