南京招聘

General summary:

The medical device safety specialist is responsible to 3D Med product regulatory compliance and risk management throughout the entire quality management system.

Duties and responsibilities:

• Function as a Regulatory Affairs subject matter expert on new product introduction and engineering design control teams. This includes conducting reviews and providing expert regulatory feedback for specifications, device testing, risk management, and other relevant documentation in accordance with regulatory requirements and with positioning for regulatory submission.
• Conduct regulatory evaluation of changes to devices in accordance with requirements of commercial/operating geography and generate the required regulatory submission (including Letters To File)
• Collate and prepare all materials, reports and follow-up with Regulatory Agencies regarding recall activity.
• Prepare documentation and reports after interpretation of global regulations for submission to governmental regulatory agencies or customers.
• Support quality system audits.
• Function as a Risk Management subject matter expert on new product development and design control team. This includes review and provides guidance on risk management (dFMEA, pFMEA and Hazard Analysis). Identify and access if the risks have mitigated and residual risks are acceptable.
• Review and assess the risk from Change control plan.
• Review and assess the risk from customer complaint.

Ensure risk assessment are performed periodically.

Essential qualifications

• BSc or Master’s Degree, in Engineering, Electronics, or Physics
• 3 years above working experience with any regulatory affairs and risk management in Medical device or IVD.
• Proven experience in Regulatory requirement and risk assessment
• Chinese (native speaker), English(fluent)
• IVDD, IVDR and FDA experience and knowledge are desirable.

Critical reasoning: Can apply knowledge of the business and key stakeholder perceptions in situation analysis and develop strategic effective messages and methods of delivery. Demonstrated ability to monitor progress and present

思路迪（3DMed）2010年成立于上海，是最早在中国展开肿瘤精准医疗检测服务的公司之一，经过长期的耕耘发展，从集团公司分拆之后的思路迪诊断，已经是中国肿瘤精准诊断领域领军企业之一，目前在中国、美国和新加坡拥有超过800名员工。
目前，思路迪诊断已经构建了集成设备工程、电气、生命科学技术、材料学和数据分析为一体的综合性研发平台，具备实现精准诊断领域研发制造全自动化操作系统的能力。其拥有自主研发的封闭式全自动化NGS文库制备平台，以及前瞻创新的肿瘤早期诊断标志物（外泌体）开发平台，促成了基于这些平台的多个突破性辅助诊断和伴随诊断产品正在临床试验阶段或即将进入临床试验；公司传染病平台开发基于自动化和POCT化的产品服务，覆盖全球传染病诊疗网络。公司还拥有第三方医学检验所，其拥有行业权威的CAP/CLIA资质，所覆盖的精准诊断营销网络超过70%的核心三甲医院，服务对象超过800家医院，提供从肿瘤早期诊断到靶向治疗、免疫治疗、再到术后动态监测的精准医疗全程管理产品和服务。