苏州招聘

Responsibilities/ Authorities工作职责权限:

·Providing professional knowledge and experience of HD machine registration within China and Asia Pacific region

·Establishing & tracking R&D registration projects, including schedule and action plan for new products or existing product changes;

·Working closely with project teams ,gather relevant information, report status.

·Preparing and maintaining R&D related product registration dossiers complying with all registration requirements;

·Establishing design control process in China team, ensure each team member got necessary process training.

·Participate as sub project manager or lead sub project managers to achieve timely product registration for Chinese market

·Establish a working interface with relevant CFDA test centers and bodies

·Establish working environment to know and test according to China and international standards

·Prepare cooperation of Fresenius teams to participate in China standard committees relevant for dialysis

·Reviewing and approving design documents, performing internal audit to ensure the development meet process requirement

·Represent the R&D team to facing external audit

·Coordinating and responding to requests for quality and registration related issue;

·Communicating with other teams within different regions, such as Asia Pacific RA team, German RA team, German product center, Headquarter QA team, etc

·Supporting other PECs on quality and registration related issue

·Attend project reviews on behalf of QA and RA

Qualifications: 任职资格

• Minimum Bachelor Degree in engineering , or related degree
• 6 or more years of experience in regulatory affairs;
• Must have working knowledge of SFDA, ISO and related regulations;
• Deep understanding of Design control process
• Good project management, problem solving and decision making skills;
• Fluent in both spoken and written English and Chinese;
• Excellent communication skills.
• Be comfortable working in a changing environment which requires flexibility and involves risk.
• Be comfortable working under pressure

费森尤斯集团（德国）是一家全球性的医疗保健服务公司,以优质的医疗产品和可信赖的治疗服务享誉全球，是世界五百强企业之一。费森尤斯集团由位于全球范围内的四个独立的事业部组成，包括费森尤斯医疗用品、费森尤斯卡比、费森尤斯赫里奥斯、费森尤斯奥美德。
江苏费森尤斯医药用品有限公司（以下简称“费森尤斯常熟工厂”）隶属于费森尤斯医疗用品，公司成立于2007年7月，是一家集研发和生产功能于一体的企业。公司主要生产用于血液透析的配套产品。现我公司诚邀勤奋敬业、不断超越自我的专业人才加入费森尤斯大家庭！
费森尤斯常熟工厂能为在职员工提供良好的培训与无限的发展空间，同时您也可以在日常工作中领略到多国文化和谐交融的氛围，提高自己的口语水平并拓宽国际视野。另外，公司还为员工提供免费工作餐及常熟市内／苏州班车、年底绩效奖金、带薪年假及其他欧美独资企业所能享有的待遇