东莞 [切换城市] 东莞招聘东莞律师/法务/合规招聘东莞合规经理招聘

资深合规经理

栢锐(东莞)科技贸易有限公司

  • 公司规模:少于50人
  • 公司性质:外资(非欧美)
  • 公司行业:贸易/进出口

职位信息

  • 发布日期:2020-09-30
  • 工作地点:东莞-寮步镇
  • 招聘人数:1人
  • 工作经验:5-7年经验
  • 学历要求:本科
  • 语言要求:英语精通
  • 职位月薪:1.2-1.8万/月
  • 职位类别:合规经理

职位描述

Report to: EVP&COO

向EVP&COO汇报


Qualification

任职资格

1. Education & Experience: Above Bachelor degree in mechanical engineering, electrical engineering, medicine,medical device or English etc.

机械类工程,电子工程,医药类,医疗器械类,英语类等本科学历以上。


2.Minimum 3 years experiences in product regulation affairs, standards and product registrations. Minimum 6 years experiences in purchasing/sourcing role with a technical background. A certain sourcing resource is required

至少3年医疗器械,化妆品法规,标准和产品注册经验;6年技术采购或供应商,新产品开发工作经验,有一定的行业采购资源。


3. Understand ISO9001/14001 /ISO13485/ 21 CFR 820/ SOR98/282-2015 / MDSAP quality management system; Understand FDA, health Canada regulation / SOR98/282-2015, MDR regulation(EU)/2047/745, CFDA regulation; be familiar with ISO22716 cosmetic GMP management system.

了解ISO9001/14001 /ISO13485/ 21 CFR 820 / SOR98/282-2015,MDSAP质量管理体系; 了解美国FDA,加拿大卫生部/ SOR98/282-2015,欧洲MDR (EU)/2047/745,中国FDA等相关法规;熟悉ISO22716化妆品良好生产规范的要求。


4.Cost analysis ability is a compulsory, Can make the break down details on the material and make the analysis to check out if the prices are reasonable.

具备成本分析能力,能够分析相关采购物料成本的详细构成,确保采购价格的合理性。


5. Knowledge of the raw materials cost movement.

专业的原材料成本结构和工艺知识。


6. Technical detail-oriented.

以技术为主,注重细节。


7.Good interpersonal, project management and presentation skills with the ability to clearly present recommendations and ideas. Good to summarize complex issues.

良好的人际关系,项目管理能力和沟通表达能力,能够清楚地提出建议和想法,善于总结和管理复杂的工作。


8. Ability to communicate in a professional and positive manner.

专业的沟通能力和积极的工作态度。


9. Highly organized self-starter, quick thinking and quick moving.

高度有组织的主动性工作,具有快速思考能力和快速取得工作进展的能力。


Responsibilities

职责

1. Price Compliance

价格审批及合规

Carry out procurement activities of raw materials to optimize supply and contribute to the optimization of the total cost of operating profit.

执行物料及服务采购活动,以优化采购为目标,以总成本的最优化为营业利润做出贡献。


  • Research and study marketing data to set price strategy of manufacturing materials.

调查并研究市场动态以设置产品物料的价格策略。


  • Focus on the trend of market prices to ensure that the purchase price is reasonable, cost-effective control.

关注市场价格趋势,确保采购价格合理、成本有效控制。


  • Cost comparison on the prices by quick checking from different channels, such as Alibaba, mfg., dragon sourcing.

能够有效的通过如阿里巴巴、生产厂、龙采购等不同的渠道,快速的运用成本比较法等来确定价格的合理性。


  • Manage to find back up vendors for price comparison and potential use.

开发可供选择的新供应商运用于价格比较和后期支持。


  • Manage the department to develop the new products.

管理部门开发新产品。


2. Regulation Compliance

产品注册及合规


  • Find and comply with suitable product standard for the registration product.

查找并遵守注册产品所适合的法规标准。


  • Work out the CE certificate for medical device, make the medical devices registration FDA, Canada, TGA, CFDA , TFDA, HSA etc. globally.

申请医疗器械CE证书,完成医疗器械在美国,加拿大,澳大利亚,中国,中国台湾,新加坡等全球注册。


  • Make the cosmetic registration and notification in China, Europe, HSA, Canada etc. globally to ensure the product safely to be launch.

完成化妆品在中国,欧洲,新家坡,加拿大等全球的注册和备案,确保产品上市前符合各国要求。


  • Monitor ISO9001/14001 /ISO13485/ 21 CFR 820/ SOR98/282-2015 / MDSAP quality management system; Ensure FDA, health Canada regulation / SOR98/282-2015, MDR regulation(EU)/2047/745, CFDA regulation and etc understood and conducted ; Monitor ISO22716 cosmetic GMP management system.

关注ISO9001/14001 /ISO13485/ 21 CFR 820 / SOR98/282-2015,MDSAP质量管理体系正常申请和运行; 确保美国FDA,加拿大卫生部/ SOR98/282-2015,欧洲MDR (EU)/2047/745,中国FDA等相关法规执行;关注ISO22716化妆品良好生产规范正常运行。


  • Other task assigned by direct superior.

其它上级分配的任务。


公司介绍

RéDUIT:
“To live smarter, more sustainable lives is something we all want. RéDUIT can help make that a reality, without the compromise.”

WELLFULLY is an international innovation company active in the design, manufacture and marketing of superior customer product technologies and solutions. When something is only good enough, it’s time to make a change. We have a passion for creating better experiences. We want to create products that perform, surprise and excite, not accepting today’s standards, but finding better ways to do things. Good ideas are a way of life.
WELLFULLY 是一家国际化创新型企业,从事设计、制造和销售,致力于向客户提供优质的产品技术和解决方案。当事物仅维持稳定安好的状态的时候,那就该做出改变了。我们拥有为创造更好体验的热情,我们希望带来有富有表现力的、令人惊喜与兴奋的产品,这不仅仅是为了符合当下的标准,更是为了寻找更好的做事方式。好的创意是一种生活方式。


The Dongguan operation center is at the core of our innovation culture. We are seeking extraordinary professionals, ready to embark on this unique adventure, and join us in solving consumer problems by addressing every design dimension, and continuously finding new ways of doing so. We don’t predict the future – we create it!
东莞运营中心是我们创新文化的核心。我们正在寻找优秀的专业人员,为这份独一无二的冒险之旅以作准备,加入我们从多个设计维度来为客户解决问题,并不停地寻找新点子来处理相关方面的问题。我们不预言未来 – 而是我们创造未来!

联系方式

  • 公司地址:地址:span横坑横西六路13号合将大厦