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3月4日刷新

法规事务经理

25-35千/月

3月4日刷新

  • 本科

  • 不限

  • 上海-浦东新区

  • 若干

  • 全职

德尔格
  • 实名
  • 其他
  • 2000以上
  • 钢铁/机械/设备/重工

招聘人员

  • 投递需要较长时间处理

职位描述

五险一金 员工福利 8小时工作制

职位类别:其它

职位描述



The Regulatory & Clinical Affairs Manager Greater China is responsible for product approvals of imported medical devices in Greater China and supporting the local approvals in target countries for products manufactured in China. He/she serves as the China focal point of contact with the Chinese Regulatory authorities and agencies.



岗位职责



Regulatory and Clinical Approval Strategy

- Develop regulatory and clinical affairs strategy and subsequent implementation plan, calibrate the regulatory and clinical affairs practice and optimize the existing system with continuous improvement

- Work with the team for local manufacture to develop and execute regulatory strategy for local manufacturing products

- Analyse and monitor requirements to register Dräger Products in markets of Greater China and drive actions to achieve all required local product approvals and registration in close collaboration with manufacturing site regulatory affairs organization



Regulatory and Clinical Approval Implementation 

- Establish a thorough submission plan with strategic thinking for each assignment within the timeline agreed by stakeholders

- Lead his/her team to manage the process for each registration based on Chinese regulation to ensure smooth and timely submission and approval with lower expense and less time

- Review and release of Conformity European (CE) technical files according to MDD93/42/EEC and 510K, serve as focal point of contact with the notified body for technical file inspections and site audits for SDMI products to be placed on the relevant markets



Communication

- Manage the communication of external regulations to Dräger Medical Greater China and Global Regulatory Affairs

- Take part in the relevant standard committee to catch up the latest information of local standards and share it with global partners

- Liaise with the relevant governmental bodies and regulatory authorities like CFDA, testing lab and CMDE



Reporting and documentation 

- Generate timeline report including all key information for other related departments every month



Leadership

- Lead and manage subordinated employees including headcount planning, recruiting, review and assessment of employees’ performance, professional development, compensation review, health & safety, motivation and enabling employees to optimize their contribution to the department, align with next higher level manager if necessary.

- Lead subordinated employees for environmental, health and safety topics. Ensure that all environmental, health and safety laws, regulations and practices are met and adhered to the protection of the environmental as well as the health and safety of employees. Ensure that full co-operation is given to the responsible persons in relation to environmental conscious behavior and processes, health working, safety training, risk assessment and accident reporting incidences.



Other assignments

- Lead local implementation of regulatory approval process and monitor project implementation and coordinate regulatory specialist resources to ensure project deliverables.

- Lead the efforts in regulatory supporting for marketing and sales in Greater China.

- Provide training to employees at Greater China on external regulations and Dräger regulatory affairs policies and procedures



任职要求



学历/Education Bachelor degree in scientific discipline, life sciences or a comparable combination of education and experience



相关工作经验/Related experience 5-8 years of experience in medical regulatory and clinical affairs,

2-3 years of experience in leading and managing employees



专业技能及相关证书

Skills, competencies, and / or certifications

- 专业方面/Professional 

- 行为方面/Behavioral Professional

- Knowledge of medical device related regulations and guidance of China and International – expert level

- Knowledge of technical standards of China and international – expert level 

- English in written and spoken – expert level

- Knowledge of ISO, MDD and 21CFR – advanced level



Behavioral

- Management competencies according to the Dräger leadership competency model – advanced level

- Ability to lead multi-level and multi-discipline work teams – advanced level

- Intercultural awareness – advanced level

  • 年龄要求: 不限
  • 语言要求:不限

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企业简介

德尔格

  德尔格是医疗和安全技术的国际先行者。德尔格 于 1889 成立于吕贝克,作为一个家族经营的企业已经历经第五代,走向了全球并且列入 DAX 指数。我们的长期成功来自于以价值为中心的公司文化和四种核心优势:与客户紧密合作、员工的专业知识、不断创新和卓越的质量。

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