Job Summary职位概述:
1. Successfully gain product registration certificates per registrationforecast plan.
依据公司产品上市计划,及时取得进口产品注册证
2. Establish an******** the goo******** close******** with officials.Builds up an******** Roche Diagnostics’ goo********.
建立并保持与政府和官员的良好关系,树立公司形象
3. Monitor an******** on local regulation changes an******** impacttogether to company. Assist manager to handle daily work in RegulatoryDept.
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
Main Tasks & Responsibilities主要工作职责 :
1. Work with sales an******** dept. to fulfill product registrationplan. Achieve 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. Establish an******** the goo******** with key contacts.Recommen******** 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, provide active an******** regulatory supports tointernal dept. 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 deal with daily works. Keep records. Have clear filingan******** 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 assigne******** line manager
主管指派的其他任务
6. Conduct business in full compliance to Behavior in Businessan******** in Competition
遵循商业行为准则,合法合理开展业务活动
Basic Requirements of the Job基本任职资格:
1. Bachelor degree or above, subject on Medical/bioengineering/ clinicalMedicine or biochemistry .
大学本科以上学历,医学/ 生物工程/ 临床或生化专业.
2. Proficiency in both spoken an******** English
熟练掌握英语口语及书面表达
3. Goo******** of MS office software application
熟练应用微软办公软件
4. Understan******** device regulation
了解医疗器械法规
Experience工作经验:
At least 2 years’ experience in medical regulatory affairs
至少2年医学法规领域工作经验
Leadership Competencies领导能力:
Leadership competencies at proficient level, in line with corporateframework.
参照罗氏集团领导能力标准和要求,领导能力达到熟练水平
Professional Competencie********专业能力/技能:
1. Consulting
顾问技巧
2. Professional Expertise
专业知识
3. Planning & Organizing
计划和组织
4. Customer Orientation & Relationship Management
以客户为中心及客户关系管理