Clinical Assessor
DNV · China
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 device’s 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。
About Life Sciences
We help our customers in medical devices, healthcare, and aquaculture/ocean industries build trust and transparency across their products, assets, and supply chains. By working with customers to certify medical technologies, support safe and sustainable healthcare practices, and advance responsible aquaculture and ocean stewardship, we help manage risks, meet regulatory demands, and achieve long-term goals. Drawing on deep technical expertise, we partner with customers worldwide to bridge trust gaps between patients, providers, producers, and consumers—driving sustainable results and improved ESG performance.
The Clinical Assessor evaluates clinical evidence and clinical documentation for medical devices and, where applicable, in vitro diagnostic medical devices. The role reviews clinical evaluation, scientific literature, clinical investigation or performance study data, and post-market clinical evidence to determine whether the submitted documentation meets applicable regulatory and DNV requirements. 临床评审员负责对医疗器械以及适用情况下的体外诊断医疗器械相关临床证据和临床文件进行评审。该岗位将审核临床评价、科学文献、临床试验或性能研究数据及上市后临床证据，以确认所提交文件是否符合适用法规及DNV要求。 The successful candidate will collaborate with auditors, technical assessors, clinicians, clinical experts and certification personnel, while maintaining independence, impartiality, integrity and professional judgment throughout the assessment process. 该岗位将与审核员、技术评审员、临床医生、临床专家及认证人员协作，并在评审全过程中保持独立、公正、诚信和专业判断。