北京招聘

职位描述：
POSITION SUMMARY:
The Senior Quality and Regulatory Affairs Specialist will be responsible for the quality assurance and regulatory affairs related work in China for Medical Device Products, mainly on quality assurance.

Essential functions (ACCOUNTABILITIES/RESPONSIBILITIES):
Quality assurance related responsibilities
1. Establish and maintain the quality management system documentations based on GSP requirements.
2. Chinese label and Chinese IFU formatting, updating and operation.
3. Cooperate with Supply Chain team on warehouse monitoring work.
4. Cooperate with Sales Operation team on complaint handling work.
5. In charge of the quality release process to domestic products in the Beijing factory.
6. Adverse Event monitoring and reporting.
7. Other quality related and regulatory compliance work.
Regulatory affairs related responsibilities
1. Prepare regulatory submission dossier packages, including communicating with global colleagues to get support, liaise and follow up with translation agencies, translation check and related administrative work.
2. Arrange the sample testing in China, including samples ordering, product standard draft and sample testing follow up at CFDA certified center.
3.Regulatory dossier submission, tracking and follow up with CFDA until the final registration approval in China.
4.Regulatory dossier filing work, including submission dossier list compiling and back-up dossier making.
Assist the manager on regulatory submission tasks for other AP countries/districts, including but not limited to Singapore, Taiwan and Vietnam.

Qualifications:

Experience
2~5 year experience in QA or RA in multinational medical device company, experience in QA is preferable.
Education
Bachelor degree in Medical Science, Pharmaceutical, Engineering, Electricity or other science related major.

Experience
2~5 year experience in QA or RA in multinational medical device company, experience in QA is preferable.
Education
Bachelor degree in Medical Science, Pharmaceutical, Engineering, Electricity or other science related major.
General Skills/Competencies/Specialized Knowledge
1. Bi-lingual Mandarin and English required.
2. Proficient in Microsoft Office Suite and other appropriate project management software.
3. Strong attention to details.
4. Be very honest, careful and responsible.
5. Strong sense of urgency on key project and be willing to sacrifice personal time when necessary.
6. Excellent communication, relationship building and interpersonal skills.
7. Task prioritization—has common sense and can apply it to management of projects.
8. Problem solver—identifies problems and solves them proactively, be creative in thinking of alternate solutions to problems. 举报 分享

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 ***************.