Regulatory Affairs Specialist / Supervisor
丹纳赫(上海)企业管理有限公司
- 公司规模:5000-10000人
- 公司性质:外资(欧美)
- 公司行业:多元化业务集团公司
职位信息
- 发布日期:2017-07-31
- 工作地点:北京
- 招聘人数:若干人
- 职位月薪:1.2-1.5万/月
- 职位类别:合规主管/专员
职位描述
职位描述:
ESSENTIAL DUTIES AND RESPONSIBILITIES:
The incumbent will also be responsible for, but not limiting to the following duties:
? Implement local type testing;
? Prepare and submit product registration documents for Class I, II, III products;
? Draft and review Chinese labels and user manuals;
? Provide the regulatory support to cross-functional team within and outside China;
? Work with individual divisions to provide necessary support to dealers and customers for regulatory compliance;
? Collect, analysis and look for the countermeasure for the new released regulation;
? Support the regulatory databases maintenance, update the databases timely.
This description is a summary of principle responsibilities and is not intended to include all duties may be assigned.
WORKING RELATIONSHIPS AND CONTACTS:
? External contacts for this position include CFDA officials, dealers and users/customers, local testing center,
? Internal contacts include headquarter, marketing team, logistic team, application and sales/service team, QA
ESSENTIAL QUALIFICATIONS:
EDUCATION & SKILLS:
? Bachelor degree or above
? Good English and Chinese language skills
WORKING EXPERIENCE:
? This position requires:
? For supervisor: at least 3 years working experience in IVD industry
? For specialist: at least 1.5 years working experience in IVD industry.
FUNCTIONAL COMPETENCIES:
? Have knowledge in CFDA regulation of medical devices and/or IVD and in CFDA registration process;
? Excellent team work and interpersonal communication skill;
? Good attitude, well habit of work, positive & take responsibility;
? Willing to focus on detailed routine work.
TRAVEL REQUIREMENTS:
This position may require business traveling in a fewness situation.
WORK ENVIRONMENT:
This position functions in a general office environment.
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ESSENTIAL DUTIES AND RESPONSIBILITIES:
The incumbent will also be responsible for, but not limiting to the following duties:
? Implement local type testing;
? Prepare and submit product registration documents for Class I, II, III products;
? Draft and review Chinese labels and user manuals;
? Provide the regulatory support to cross-functional team within and outside China;
? Work with individual divisions to provide necessary support to dealers and customers for regulatory compliance;
? Collect, analysis and look for the countermeasure for the new released regulation;
? Support the regulatory databases maintenance, update the databases timely.
This description is a summary of principle responsibilities and is not intended to include all duties may be assigned.
WORKING RELATIONSHIPS AND CONTACTS:
? External contacts for this position include CFDA officials, dealers and users/customers, local testing center,
? Internal contacts include headquarter, marketing team, logistic team, application and sales/service team, QA
ESSENTIAL QUALIFICATIONS:
EDUCATION & SKILLS:
? Bachelor degree or above
? Good English and Chinese language skills
WORKING EXPERIENCE:
? This position requires:
? For supervisor: at least 3 years working experience in IVD industry
? For specialist: at least 1.5 years working experience in IVD industry.
FUNCTIONAL COMPETENCIES:
? Have knowledge in CFDA regulation of medical devices and/or IVD and in CFDA registration process;
? Excellent team work and interpersonal communication skill;
? Good attitude, well habit of work, positive & take responsibility;
? Willing to focus on detailed routine work.
TRAVEL REQUIREMENTS:
This position may require business traveling in a fewness situation.
WORK ENVIRONMENT:
This position functions in a general office environment.
职能类别: 合规主管/专员
公司介绍
丹纳赫是全球科学和技术的创新者,致力于帮助我们的客户在全球各地应对复杂的挑战和改善生活品质。我们在最前沿和富有吸引力的领域,如生命科学、环境等等,拥有众多世界一流的品牌。我们是一支全球超过71000名员工的多样化团队,遵循同一个文化 - 丹纳赫业务运营体系(DBS),该体系引领我们始终在日益激烈的商业竞争中处于领先地位。丹纳赫2014年营业额达到199亿美金并且市值超过600亿美金,位列美国财富500强中的149位。在过去的20年中,丹纳赫的股价表现优异,超过标准普尔指数将近2000%。
在中国,丹纳赫始终保持高速增长,拥有超过6000名员工和16亿美金的营业额。二十多家中国营运公司和超过一百家的分支机构,不但为中国客户提供着全方位的产品和服务,也为卓越人才提供更好的工作机遇和职位发展平台。
了解更多信息,请访问公司网站:***************.
Danaher is a global science and technology innovator committed to helping our customers solve complex challenges and improve quality of life around the world. Our family of world class brands have unparalleled leadership positions in some of the most demanding and attractive industries, including health care, environmental and etc. We are a globally diverse team of 71,000 associates united by a common culture and operating system, the Danaher Business System, which serves as our ultimate competitive advantage. In 2014, we generated $19.9 billion in revenue and our market capitalization exceeded $50 billion. We are ranked #149 on the Fortune 500 and, during the past 20 years, our stock has outperformed the S&P 500 Index by nearly 2,000 percent.
With over 6000 associates and $1.6 billion of revenue in China, Danaher continuously achieve high growth in the market. Through more than 20 China operation companies and more than 100 subsidiaries, Danaher not only provides comprehensive products and services to China client, but also better career opportunities and development platform for talents.
For more information please visit our website at ***************.
在中国,丹纳赫始终保持高速增长,拥有超过6000名员工和16亿美金的营业额。二十多家中国营运公司和超过一百家的分支机构,不但为中国客户提供着全方位的产品和服务,也为卓越人才提供更好的工作机遇和职位发展平台。
了解更多信息,请访问公司网站:***************.
Danaher is a global science and technology innovator committed to helping our customers solve complex challenges and improve quality of life around the world. Our family of world class brands have unparalleled leadership positions in some of the most demanding and attractive industries, including health care, environmental and etc. We are a globally diverse team of 71,000 associates united by a common culture and operating system, the Danaher Business System, which serves as our ultimate competitive advantage. In 2014, we generated $19.9 billion in revenue and our market capitalization exceeded $50 billion. We are ranked #149 on the Fortune 500 and, during the past 20 years, our stock has outperformed the S&P 500 Index by nearly 2,000 percent.
With over 6000 associates and $1.6 billion of revenue in China, Danaher continuously achieve high growth in the market. Through more than 20 China operation companies and more than 100 subsidiaries, Danaher not only provides comprehensive products and services to China client, but also better career opportunities and development platform for talents.
For more information please visit our website at ***************.
联系方式
- Email:jwu2@hach.com
- 公司地址:长宁区福泉北路518号2座 (邮编:200120)