Clinical Assessor

Clinical Assessment / 临床评审

• Review and assess Clinical Evaluation Reports (CERs) Performance Evaluation Reports (PERs) and supporting clinical evidence.
  评审临床评价报告CER性能评价报告PER及相关支持性临床证据

• Evaluate the adequacy scientific validity relevance and consistency of clinical data supporting device safety performance and clinical benefit.
  评价支持产品安全性性能及临床获益的临床数据是否充分科学相关且一致

• Critically appraise scientific publications literature reviews clinical investigation reports performance study reports and post-market clinical evidence.
  对科学文献文献综述临床试验报告性能研究报告及上市后临床证据进行批判性评价

• Assess clinical benefit-risk conclusions and the alignment of clinical evidence with the devices intended purpose indications and target population.
  评估临床获益风险结论以及临床证据与产品预期用途适应证和目标人群的一致性

• Identify gaps deficiencies inconsistencies and regulatory non-conformities in submitted documentation.
  识别所提交文件中的缺口不足不一致及法规不符合项

Assessment Delivery and Collaboration / 评审交付与协作

• Prepare clear evidence-based technically sound and timely assessment reports and conclusions.
  编写清晰基于证据技术判断充分且及时的评审报告与结论

• Participate in multidisciplinary MDR/IVDR conformity assessment teams within the scope of assigned competence.
  在获授权的能力范围内参与MDR/IVDR跨专业符合性评审团队工作

• Communicate assessment findings and requests for clarification effectively to internal stakeholders and customers as applicable.
  根据需要向内部相关方及客户清晰沟通评审发现和补充资料要求

• Collaborate with relevant technical and clinical experts when specialist input is required.
  需要专业意见时与相关技术专家及临床专家协作

• Plan and manage assigned assessments to meet agreed quality and delivery expectations.
  规划并管理所分配的评审工作满足既定质量及交付要求

Competence and Continuous Improvement / 能力保持与持续改进

• Maintain current knowledge of applicable medical device regulations guidance documents clinical research methods and relevant therapeutic developments.
  持续掌握适用的医疗器械法规指导文件临床研究方法及相关治疗领域的发展动态

• Complete required training qualification and competence maintenance activities.
  完成岗位要求的培训资格认定及能力保持活动

• Contribute to the improvement of assessment methods templates and internal processes.
  参与评审方法模板及内部流程的持续改进

• Perform other reasonable duties assigned by the line manager.
  完成直线经理安排的其他合理工作