Regulatory Compliance Manager
新美亚通讯设备(苏州)有限公司
- 公司规模:150-500人
- 公司性质:外资(欧美)
- 公司行业:通信/电信/网络设备
职位信息
- 发布日期:2012-08-20
- 工作地点:苏州
- 招聘人数:1
- 工作经验:八年以上
- 学历要求:本科
- 语言要求:英语精通
- 职位类别:合规经理
职位描述
Develop and implement strategies to facilitate the progress of Sanmina-SCI's worldwide medical division;
Work with assigned Medical Division facilities on conformance to company quality and regulatory initiatives;
Serve as liaison with the FDA and other regulatory agencies as assigned;
Interface with plant management teams, customers and notified bodies as assigned;
Review technical reports and summary documents for adherence to regulatory guidelines, strategies, and commitments; Recommend regulatory policies to assure adherence to FDA requirements;
Contribute to the modification, development and implementation of company practices and policies for quality and regulatory affairs;
Assist in the scheduling and tracking of project and operational activities for the Medical Division;
Keep abreast of all pertinent laws, regulations and guidance and provide insight on current regulations and guidance documents relevant to product development projects;
Provide input on regional regulatory strategies and implementation activities;
Prepare Standard Operating Procedures and provide review of SOPs as necessary.
QUALIFICATIONS:
? Bachelor's degree in a scientific discipline.
? Expert knowledge of FDA regulations.
? At least 7 years experience in a Quality/Regulatory and manufacturing environment.
? Experience with Device submissions is a plus. (510K, PMA, IDE)
? Strong written and verbal communication skills necessary.
? Proficient use of technology including MS Office Software Package and Internet resources is expected.
? Must demonstrate professionalism in all working environments.
? Must be able/willing to travel globally, approximately 7-10 times per year.
Work with assigned Medical Division facilities on conformance to company quality and regulatory initiatives;
Serve as liaison with the FDA and other regulatory agencies as assigned;
Interface with plant management teams, customers and notified bodies as assigned;
Review technical reports and summary documents for adherence to regulatory guidelines, strategies, and commitments; Recommend regulatory policies to assure adherence to FDA requirements;
Contribute to the modification, development and implementation of company practices and policies for quality and regulatory affairs;
Assist in the scheduling and tracking of project and operational activities for the Medical Division;
Keep abreast of all pertinent laws, regulations and guidance and provide insight on current regulations and guidance documents relevant to product development projects;
Provide input on regional regulatory strategies and implementation activities;
Prepare Standard Operating Procedures and provide review of SOPs as necessary.
QUALIFICATIONS:
? Bachelor's degree in a scientific discipline.
? Expert knowledge of FDA regulations.
? At least 7 years experience in a Quality/Regulatory and manufacturing environment.
? Experience with Device submissions is a plus. (510K, PMA, IDE)
? Strong written and verbal communication skills necessary.
? Proficient use of technology including MS Office Software Package and Internet resources is expected.
? Must demonstrate professionalism in all working environments.
? Must be able/willing to travel globally, approximately 7-10 times per year.
公司介绍
SANMINA-SCI是全球首要的多元化、国际化电子产品契约制造商,总部位于加利福尼亚洲SAN JOSE。主要生产交易自动化系列产品,开发相关软体,加工制造印刷线路板组合,电子系统装置,提供电子产品的设计,制造销售等相关的服务;产品涉及个人电脑,宇航工业,防御体系,半导体、电信、汽车、医疗及娱乐设施 等诸多领域。Sanmina-SCI在全球有100余家工厂,分布于22个国家和地区。
SANMINA-SCI通讯设备系统在全球有22家工厂,分布于10个国家。主要的生产工艺包括:钣金冲压、折弯、紧固件、焊接、化学表面处理、静电粉末喷涂、组装和测试。
新美亚通讯设备(苏州)有限公司是Sanmina-SCI投资兴建的一家独资公司,投资总额三千万美元。主要生产医疗设备,工业打印机系统和集成,高档服务器、基站及交换设备的外壳等相关产品。热烈欢迎相关人才加盟与公司共同成长。
抵达新美亚苏州的交通路线:
乘6,400路公交车至“金枫路鹿山路西”站点下,步行至金枫路向北第二家公司。
SANMINA-SCI通讯设备系统在全球有22家工厂,分布于10个国家。主要的生产工艺包括:钣金冲压、折弯、紧固件、焊接、化学表面处理、静电粉末喷涂、组装和测试。
新美亚通讯设备(苏州)有限公司是Sanmina-SCI投资兴建的一家独资公司,投资总额三千万美元。主要生产医疗设备,工业打印机系统和集成,高档服务器、基站及交换设备的外壳等相关产品。热烈欢迎相关人才加盟与公司共同成长。
抵达新美亚苏州的交通路线:
乘6,400路公交车至“金枫路鹿山路西”站点下,步行至金枫路向北第二家公司。
联系方式
- 公司地址:上班地址:新区金枫路299号