Medical Devices are some of the most regulated products in the world. In this role, you will be a part of the UL Medical Regulatory Team. Working with limited supervision, you will independently assist and support processing of manufacturer submissions to the Medical Device Directive 93/42/EEC and the Medical Device Regulation 2017/745, ISO13485 and MDSAP. Within the framework of our highly regulated Notified Body you will:

• Support contract review / project planning for technical file and quality management system audits.

• Assess technical file and quality management systems against European Directive 93/42/EEC and 2017/745, essential requirements standards and MEDDEV requirements

• Support regular quality system and technical audits, including unannounced audits.

• Subject to training and qualification milestones, perform key CE conformity assessment activities to support safe products to market.

• Perform development and support of UL’s Conformity Assessment processes for CE certifications;

• Support Competent Authority activities on as needed basis e.g. Competent Authority audits of UL.

• Participate in the development of UL requirements and assessment methods. Integrate continuous improvement concepts into all aspects of the job.

• Provide guidance and support to customers as required. Participate in client training and customer forums.

UKDomestic/Overseas travel is required.

• 针对技术文件和质量管理体系的审核项目，协助完成合同评审和项目计划

• 根据欧盟MDD/MDR要求，以及相应医疗器械标准中的要求，审核技术文件和质量管理体系

• 能够与Lead Auditor一起完成现场的质量体系和技术审核工作

• 在有必要时，完成授权机构（如美国FDA，英国MHRA等）要求的活动，如见证审核

• 为销售、培训、市场和客服人员提供技术支持以服务客户

• 与部门团队密切合作，维系与客户良好商业合作关系和发掘新的商业机会，提升现有客户的满意度

• 不断提升审核技能，并持续学习质量管理体系标准以及有源医疗器械产品等相关知识

• 能够适应经常性的国内出差，以及疫情之后亚太区域内的国际差旅

• At least a Degree or equivalent in Life Science or Electrical / Electronics, etc;

• At least 7 years hands-on experience within the Medical Device Industry a solid knowledge of product design and preferably additional a good understanding of activities and processes within manufacturing or quality assurance/ regulatory affairs;

• Experienced with standards such as IEC 60601 series of standards, biocompatibility, ISO 10993 standard, software IEC 62304 for the products you have work with is essential

• Experience of risk management whether compiling the RM file or participating in the RM process according to ISO 14971 standard is required;

• Experience working under an ISO 13485 quality system is advantageous

• Registered China CCAA QMS auditor is advantageous

• 具有生命科学/电子电器相关专业本科或本科以上学历

• 至少7年医疗器械行业相关经验，良好的产品设计知识，了解质量生产或QA/RA标准/监管等相关活动及流程

• 了解相关医疗器械产品的安规IEC60601系列标准；，生物相容性，ISO 10993系列标准，同时有以及软件IEC62304相关标准经验

• 有风险管理经验，包括编写RM文件或参与ISO 14971 标准的RM流程

• 有ISO 13485 质量体系工作经验者优先

• 中国CCAA注册QMS审核员优先

• 工作地点不限，华东区域优先