上海招聘

职位描述：
职位描述

Senior Clinical Affairs Specialist is responsible for all the clinical affairs related to Chinese authority including defining clinical needs, drafting clinical evaluation report with clinical support from legal manufacturer. He/she leads clinical trial in China if necessary. He/she coaches level below Clinical Affairs Specialist.
岗位职责

Clinical Affairs
- Define clinical needs for initial/change registration of our products according to regulations of CFDA (China Food and Drug Administration).
- Draft and accomplish clinical evaluation reports for assigned projects with support from legal manufacturer to fulfil the requirement of CFDA.
- Establish a clinical database according to the CFDA requirements for each product family with identifying the lag between Chinese and European CERs (Clinical Evaluation Report).
- Take the responsibility to communicate with the CFDA reviewers to fulfill the requirements of the CER and also to closely monitor any changes in this field including regulatory requirements. Furthermore, all those Chinese clinic related requirements should be communicated internally and also with the legal manufacturer.
- Communicate with Product Manager to carry out clinical trial to fulfill the CFDA requirements if necessary.
- Organize clinical trial if necessary by engaging the third party and/or supporting from internally.
- Execute the day to day operation activities so that clinical sites follow protocol rules and applicable regulations.
- Track site status in a timely manner and provide feedback or improvement recommendations to management (including pre-study visits, close-out visits and interim monitor visits) as a clinical inspector.
- Act as an expert to support clinical issues internally/externally.

Act as a coach
- Coach level below Clinical Affairs Specialist if necessary.

Documentations
- Archive all clinical related documents for external audit.
任职要求

Bachelor degree in clinic or biomedicine or a comparable combination of education and experience

5-8 years experiences in Clinical Affairs, medical industry or hospital
Project management experience is preferred

Professional Competencies:
- Knowledge of medical device related Chinese and International clinical regulations and guidance– expert level
- Knowledge of Chinese and international technical standards – advanced level
- Knowledge of at least one Dräger related product line – advanced level
- English in both written and oral – advanced level

Behavioral Competencies:
- Act reliably – advanced level
- Think analytically – advanced level
- Learn and develop – advanced level
- Cooperate knowledge – advanced level
- Act as a coach – advanced level 举报 分享

德尔格公司早在本世纪五十年代便开始活跃于中国医疗设备和工业安全产品的各大领域。德尔格的开拓者们始终坚守着“大胆创新、以质取胜”的办事原则，在中国赢得了一定的市场份额。为了确保产品适应于中国市场和保证德尔格在世界各地所公认的售后服务质量，德尔格分别于一九九四年和二〇〇〇年在上海投资和建立了公司，负责德尔格公司和北美德尔格公司在中国的一切业务，并拥有雇员近五百人。
As early as in the 1950s Draeger Company was already actively engaged in various fields of medical equipment and industrial safety products in China. Always adhering to the principle of "brave innovation and being quality-centered", the explorers of Draeger have won certain market share in China. In order to make sure that Draeger products accord with the Chinese market and to ensure the qualify of after-sales service by Draeger that is recognized world wide, Draeger Medical invested to establish Shanghai Draeger Medical Instrument Company Limited (SDMI) in 1994 and Draeger Medical Equipment (Shanghai) Company Limited (DME) in 2000, respectively, in Shanghai to be responsible for all businesses of Draeger (Germany) Company and Draeger (North America) Company in China, and nearly 500 persons were employed.

德尔格医疗设备（上海）有限公司是一家由德尔格股份有限公司投资成立的独资企业。目前公司分别在北京、广州、成都、西安设有分公司，在台湾与香港分别设有两个独立的法人公司。公司销售和提供服务的产品覆盖麻醉、呼吸、急救、新生儿、医疗供气系统、吊臂设备、床头设备、手术台、手术灯、净化室 等各个领域。
Draeger Medical Equipment (Shanghai) Company Limited (DME) is an enterprise solely invested by Draeger Medical Joint Stock Company Limited. At present, four branches have been established in Beijing, Guangzhou, Chengdu and Xian, and two independent incorporated companies, Draeger Medical Equipment (Hong Kong) Company Limited and Draeger Medical Equipment (Taiwan) Company Limited, have been set up in Taiwan and Hong Kong, respectively. The company sells products and provides services that cover various fields such as anesthesia, breathing, emergency care, newborn infants, medical gas supply systems, arm-suspension equipment, bedside equipment, operating tables, operating lamps and decontamination chambers etc.

愿景
Vision
我们是即时医疗解决方案的首选合作伙伴，并能吸引本行业最优秀的人才。
We are the preferred partner for Acute Point of Care Solutions - and are able to attract the best people in the industry

使命
Mission
我们承诺我们的服务是符合大中华区的客户需求。我们的使命是在病人治疗的全过程中提供有效和成本优化的解决方案-从急救、治疗、手术室和麻醉，到危重症治疗、围产期治疗和家庭治疗。
We are committed to meeting out specific customer needs in Greater China. Our mission is to create effective. Cost-efficient solutions throughout the patient care process from Emergency Care, OR and Anesthesia, to Intensive Care, Perinatal Care and Home Care.

德尔格中国公司文化的核心原则
Core Principle of Corporate Culture for Draeger China
团队合作 Teamwork
尽心尽责 Ownership
积极进取 Passion
正直诚信 Integrity
客户至上 Customer Orientation

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