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 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。 • Flexible work arrangements for better work-life balance • Generous Paid Leaves (Annual Paid Leave, Sick Leave) • Medical benefits (Standard medical check-up) • Pension and Insurance Policies • Training and Development Assistance (Training Sponsorship, On-The-Job Training, Training Programme) • Additional Benefits (Long Service Awards, Mobile Phone Reimbursement, Professional Membership Fees) *Benefits may vary based on position, tenure/contract/grade level* DNV is an Equal Opportunity Employer and gives consideration for employment to qualified applicants without regard to gender, religion, race, national or ethnic origin, cultural background, social group, disability, sexual orientation, gender identity, marital status, age or political opinion. Diversity is fundamental to our culture and we invite you to be part of this diversity. Education / 教育背景 • Bachelor’s degree or above in Clinical Medicine. 临床医学专业本科及以上学历。 • A master’s degree, doctoral degree, recognized medical qualification or physician practice experience is an advantage. 具有硕士、博士学历、认可的医学专业资格或医师执业经历者优先。 Required Experience / 必备经验 • At least four years of hospital-based clinical practice experience. 具有 4 年以上医院临床工作经验。 • Sound knowledge and practical understanding of one or more relevant therapeutic areas. 熟悉一个或多个相关治疗领域，并具备相应临床实践理解。 • Familiarity with clinical research principles, study design and Good Clinical Practice (GCP). 熟悉临床研究原则、研究设计及药物 / 医疗器械临床试验质量管理规范（ GCP）。 • Demonstrated ability to search, read, interpret and critically evaluate clinical and scientific literature. 具备临床及科学文献检索、阅读、解读和批判性评价能力。 • Good English reading, writing and verbal communication skills, including the ability to review scientific and technical documentation in English. 具备良好的英文阅读、写作及口头沟通能力，能够独立审阅英文科学与技术文件。 • Strong communication and interpersonal skills. 具备良好的沟通协调及人际交往能力。 Preferred Experience / 优先条件 • Experience involving medical devices, in vitro diagnostics, clinical investigations, clinical research organizations, regulatory affairs or quality management. 具有医疗器械、体外诊断、临床试验、临床研究机构、法规事务或质量管理相关经验。 • Knowledge of EU MDR, EU IVDR, ISO 13485, relevant MDCG guidance or other medical device regulatory frameworks. 了解欧盟 MDR 、欧盟 IVDR、ISO 13485 、相关 MDCG 指导文件或其他医疗器械法规体系。 • Experience preparing or reviewing clinical evaluation, performance evaluation, PMCF/PMPF or post-market surveillance documentation. 具有临床评价、性能评价、 PMCF/PMPF 或上市后监督文件编写或评审经验 Security and compliance with statutory requirements in the countries in which we operate is essential for DNV. Background checks will be conducted on all final candidates as part of the offer process, in accordance with applicable country-specific laws and practices.