苏州 [切换城市] 苏州招聘苏州质量管理/安全防护招聘苏州认证工程师/审核员招聘

Regulatory Specialist

史赛克(苏州)医疗技术有限公司

  • 公司规模:150-500人
  • 公司性质:外资(欧美)
  • 公司行业:医疗设备/器械

职位信息

  • 发布日期:2014-07-31
  • 工作地点:苏州
  • 招聘人数:1
  • 工作经验:3-4年
  • 学历要求:本科
  • 职位月薪:面议
  • 职位类别:体系工程师/审核员  认证工程师/审核员

职位描述

Responsibility:

Responsible for ensuring Regulatory Compliance for the facility and products produced by Stryker. Creates and drives a culture of Quality and Compliance assisting the organization to ensure the promotion and awareness of regulatory requirements.
1. Creates and drives a culture of Quality and Compliance.
2. Continuously fully comply with all GMP and Regulatory requirements.
3. Provide guidance on Quality Assurance/GMP/FDA-QSR and CFDA related topics
4. Involved in developing, modifying, and executing regulatory related company guidelines and procedures.
5. Prepare registration dossier based on registration planning and regulatory authorities requirements, including new and renewal registration.
6. Outline the regulatory requirements associated with quick win projects or specific projects including providing regulatory counsel at the team meeting and identifying the need for regulatory involvement.
7. Co-ordinate and communicate with project team to work out the registration time schedule according to Product Development Procedure in place.
8. Build the process for handling post market issues for product that is produced by Suzhou.
9. Will train others and the organization to the applicable GMP/FDQ-QSR/and local regulatory standards.
10.Support to any regulated external inspection, ie. FDA / CFDA / or other government body.
11.Develop relationship with the corporate, Greater China, and Divisional regulatory teams.
12. Other tasks assigned by Supervisor.



Skill sets:

1. Good understanding for regulations and policies issued by FDA, CFDA etc.
Must be able to analyze and resolve non-routine product issues using independent judgment.
2. Demonstrated planning and organizing, customer focus, and cross-functional/teamwork skills
3. Registration experience on CFDA Product Registration, CE mark, or registration outside of China is preferred



Experience:

1. 2-5 years’ experience in preparing regulatory submissions or equivalent experience within a medical device or pharmaceutical environment
2. Excellent written and verbal communication skills, and proficiency in English.
3. Excellent interpersonal skills
4. Excellent organizational skills
5. CFDA Class I and Class II product registration experience is preferred

6. B.S. is preferred, or related discipline
7. Project management skill is a Plus.

公司介绍

我们,来自美国!
我们,创建于1941年,并已发展为全球规模最大、技术最为领先的医疗技术公司之一!
在全球拥有29个生产和研发基地;
在全球100多个国家和地区销售产品;
拥有近22000余名优秀的员工!
2013年全球业务超90亿美金,并连续32余年保持业务增长——平均每年增长19%!
在骨科植入物、手术介入治疗设备、医疗通讯、数字化影像系统等医疗领域引领技术创新
2012在《财富》500强中排名第308位,并在由《财富》评选的“最受敬仰的医疗设备及其它精密设备行业”
      中排名第6!
我们,多次荣获盖洛普公司评定的“***工作场所奖”
我们,曾于2005-2008年连续4年获得医疗产品和医疗器械行业“最受尊敬企业”荣誉;
我们,曾于2007-2009年连续3年被授予盖洛普“***雇主奖”
我们,被《中国医疗设备》评选为“2010年优秀售后服务商第2名”
我们,于2011年被《福布斯》杂志授予全球“最具创新力”公司;
我们,于2010-2013连续4年被《财富》杂志授予美国“***工作场所奖”;
……
这,就是史赛克医疗技术有限公司!

史赛克(苏州)医疗技术有限公司成立于2007年11月,位于苏州工业园区出口加工区a区,为史赛克集团在亚洲投资的第一个制造工厂,公司将快速成长为集团最大的综合性生产基地之一、并肩负起为集团全球业务供应众多优质治疗产品的使命!
在史赛克苏州,
我们有一个激情洋溢、追求卓越的团队;
我们为员工提供极具竞争力的薪资报酬;
我们致力于创造优质的医疗产品,以帮助人们更为健康、快乐的享受生活!

如果您正在寻找一份与众不同的工作经历,来吧,加入史赛克!

在史赛克,你的天赋将不断地被发现、强化和运用!


更多公司信息请浏览公司网站:www.stryker.com

联系方式

  • 公司地址:上班地址:江苏省苏州市工业园区苏虹中路200号出口加工区A区吴巷18号