天津招聘

岗位职责
？ Drive Management of quality and regulatory site personnel
？ Provide Regulatory guidance for contract manufactured product and locally designed product
？ Accountable to Quality Management Team for implementing and reporting site activities
？ Lead quality and regulatory compliance for Importation, Distribution and Manufacturing as required for “real-time” decisions that affect our business
？ Assure Compliance Policy adherence
？ Achieve and maintain consistent Global compliance, trending and monitoring
？ Assure continuous improvement of quality, reliability, and safety information flow to ensure accountability
？ Implement and lead all quality activities that support the Management Team’s strategic plan
？ Use CDTR, CSS, DfR and QSB to improve product and process quality
Be responsible for handling of escalation and proper conduct


岗位要求
？ 10 years of experience is in relevant Quality and Regulatory compliance roles in the Manufacturing or Importing/Distribution of Medical Equipment; and > 5 years as supervisor or manager role.
？ Experience and comprehensive understanding of Regulatory compliance in the Manufacturing or Importing/Distribution of Medical Equipment globally
？ Experience in development and submittal of documentation related to MDRs, FCAs, Recalls, Corrections & Removals and Market Withdrawals
？ FDA, cGMP., cGDP and related audit readiness planning and implementation
？ Ability to comprehend scientific applications issues and solve problems effectively
？ Strong communications skills .
？ Fluent in English and Mandarin
？ Ability to interact with various people in a calm and positive manner (including global Regulating Bodies)
？ Good time management
？ Self-motivated
？ Ability to effectively communicate information to groups of participants at all levels of organization
？ Proficient in computer skills and knowledgeable in required Complaint Handling software

？ Superior English communications
？ Extensive regulatory assurance experience in new product development (Design & Development Project team work)
？ Good soft skills to influence and educate other departments
？ Strong work history in medical devices environment
Extensive knowledge of Quality Management Systems in a manufacturing environment
Work history of people//process//project management in related fie

普瑞斯（presearch）管理咨询公司(www.presearchina.com)是一家为企业提供国内外中高端人才引进、甄选、举荐和核心人才定向猎聘服务的专业猎头公司。成功为数十家世界500强国际著名的跨国公司、国内著名的大型企业集团和上市公司提供了满意的猎头服务，并与多家实力企业建立了长期稳定的人力资源战略合作伙伴关系，猎头领域涉及制造业、IT通讯、房地产、医疗机械、消费电子、服装、等行业。
普瑞斯拥有在各个行业多年从业经验的资深猎头顾问，我们与国内知名猎头网站合作拥有近50万的人才数据共享资源，能够快速响应各类企业的不同需求，公司以客户满意度为宗旨，正以迅猛发展的态势形成辐射全国的战略经营格局，力求成为企业最忠实长久的合作伙.

加入普瑞斯您可以获得：
开心的工作环境；
丰富的猎头技巧培训；
完善的薪资福利；
良好的职业成长通道。