工作职责：职位概述 Job Summary : 1. Establishes and maintains the good and closed relationship with CFDA testing centers. And successfully gains product registration certificates per registration forecast plan. 和全国各 CFDA 检测 中心保持良好关系，依据公司产品上市计划顺利取得进口产品注册证书。 2. Establishes and maintains the good and closed relationship with hospital IVD departments (clinical Lab, drug monitoring lab, GCP, etc…). And builds up and represents Roche Diagnostics’ good image, and gain products clinical trial reports per action plan. 建立并保持与 IVD 临床机构（检验科，药 剂科，药理基地等）的良好关系，树立公司形象，并及时取得临床试验报告。 3. Monitors and reports on local regulation changes and its impact together to company. Assists manager to handle daily work in Regulatory Dep.将信息和政策导向及时通知公司。协助经理处理日常法规 问题 主要工作职责 Main Tasks & Responsibilities : 1. Works with sales and marketing dep. to fulfill product registration plan. Achieves RD expectation on product registration.与销售和市场部配合，完成注册计划。达到公司对产品注册的要求。 2. Establishes and maintains the good relationship with key contacts. Recommends valuable suggestion to company 建立并保持与政府部门及重点客户的良好关系，为公司提供有价值的意见。 3. As a member of RD, provides active and strong regulatory supports to internal dep. as needed.作为团 队的一分子,积极为各部门和内部员工提供及时和有力的政策法规的支持。 4. Initiatively deals with daily works. Keeps records. Has clear filing and maintain of all documents.积极 主动处理其他日常法规问题。做好工作记录。文件分类归档，保留完好。 5. Other projects or tasks assigned by line manager 主管指派的其他任务 6. Conduct business in full compliance including but not limited to Roche Secure, Roche Behavior in Business, Roche Competition Law Interactive Dialogues, Roche Safety, Security Health and Environmental Protection 遵循、所有合规要求，包括但不限于、信息安全，、商业中的行为，、竞争法互动对 话，罗氏安全健康环境等，合法合理开展业务活动
任职资格：基本任职资格 Basic Requirements of the Job : 教育背景 Education : Bachelor degree or above, subject on Medical/bioengineering/ clinical Medicine or biochemistry . 大学本科以上学历，医学/ 生物工程/ 临床或生化专业. 工作经验 Experience : 1. Have not less than 2 years about experience in medical regulatory affairs, focus on testing center and clinical trial. Understand IVD products’ Standard like industry and national standards( YY and GB)有 2 年以上医学法规领域的经验 ，有注册和临床经验优先。 了解 IVD 产品标准（行业和国家标准）。 2. High enthusiasm and devotion, work hard and earnest 具有强烈的事业心，工作仔细认真。 3. Willing to work under pressure, self-starting and self-inspiring 能承受高强度的工作压力，积极主动 并自我激励。 4. Be honest and open, excellent interpersonal communication skill, ability of social activity and collaboration 为人诚实、开朗，善于与人沟通和合作，有较强的社会活动能力。 5. Innovating with good independent working ability 在工作中不断创新，能独立处理问题。 6. Energetic team spirit 有团队合作精神。 专业知识与资格 Specific Knowledge & Qualifications: 1. Medical laboratory background. 医学检验学科背景优先。 2. Familiar with medical device regulation. 熟悉医学法规。 3. Fluent English in listening, speaking and written. 英语流利，听说读写俱佳。 4. Good skill on computer, MS-Office operation. 熟练操作 MS-OFFICE 软件。 专业能力/技能 Professional Competencies/skills: 计划和组织 Planning & Organization 1. Meets Roche and government standards 达到罗氏和政府标准 2. Complies with policies 遵守相关政策 3. Identifies the most important tasks and concentrates on them 确定最重要的任务，并集中精力完成 这些任务 4. Handles problems promptly 及时处理问题 以顾客为本与关系管理 Customer Orientation & Relationship Management 1. Acts a bridge between various internal and external stakeholders 作为内外不同利益相关者之间的桥梁 2. Sets goals with the needs of stakeholders in mind 根据利益相关者的需要来设定目标 3. Maintains frequent communication with internal customers and stakeholders 定期与内部客户和利益相关者沟通 4. Addresses internal and external customer requests in a timely way 及时处理内外客户的需求 5. Listens to different opinions from internal stakeholders 聆听内部利益相关者不同的意见 6. Manages suppliers efficiently and effectively 高效地管理供应商 7. Demonstrates sound judgment during negotiations 磋商期间做出良好判断 顾问技巧 Consulting 1. Clearly understands the needs of internal customers and stakeholders 清楚了解内部客户和利益相关者的需要 2. Communicates relevant professional knowledge to others in a way that they can understand it 向其他人员传达相关的专业知识，并使他们明白 3. Promotes concepts and programs effectively to internal customers 有效地向内部客户推广有关概念和方案 4. Works to make processes transparent, systematic, and interactive with some success 努力令流程变得透明、互动和有系统，而且取得一些成功 5. Provides sound professional advice related to processes 提供有效的流程相关的专业建议 6. Makes announcements on relevant processes in a timely way 对相关的流程及时做出通告 7. Ensures full compliance with relevant policies 确保切实遵守有关政策
