南京招聘

Mission of Function:

- Guide new products through the regulatory process for X-ray products.

- Regulatory testing/Market clearances of XP system (IEC/CE, UL/FDA, SFDA/CCC, etc.)

Contacts(internal /external):

- Internal: SSME XP engineering, SSME QP, SLC Regulatory, Regulatory affairs XP at headquarters in Germany, Engineering at XP headquarters in Germany

- External: SFDA, CQC, test institutes

Areas of Responsibility / Tasks:

- Definition of regulatory requirement specification for global certification of X ray equipment.

- Support licensing documentation and work together with engineering and QP.

- Regulatory testing/Market clearances of XP system (IEC/CE, UL/FDA, SFDA/CCC, etc.)

- Create regulatory compliance / project plan using Regulatory Intelligence and in collaboration with Region RA to ensure all requirements are met for country submissions timely; Competencies Techniques (Technologies / Methodologies / Professional Knowledge)

- Engineering (preferably electromechanical) background, if possible in medical equipment industry

- Familiarity with IEC 60601-1 series standards

- Know-how for regulatory and licensing work in China, if possible in medical equipment industry

- Familiarity with X-ray product portfolio (especially technical knowledge)

- Assertiveness and result-orientation

- Definition of licensing-related documentation (e.g. product description report and product standard)

- Good communications skill for internal and external communication

- Experience in working in a cross-cultural environment

- Fluent English (spoken and written)

Essential (today and in future):

- Professional Variety of Business:

- Several years experience in function that provides good technical insight into X-ray product portfolio (e.g. customer service) and/or several years experience in function related to product licensing work for Chinese market (preferably in medical equipment industry or test institute)

- Familiarity with X-ray product portfolio desirable

- Familiarity with technical standards (SFDA, CQC, IEC etc.) desirable

- Experience in working in virtual teams across different locations and countries

Intercultural Variety of Cultures:

- Working experience in an intercultural environment desirable EDGE

- Strategic judgment

- Entrepreneurial spirit ENERGY

- Initiative

- Change orientation

- Learning ENERGIZE

- Communication Skills

- Network built on trust

- Team player EXECUTE

- Analytics

- Decision making

- Result and quality orientation PASSION

- Professional ethics

Siemens values Education:

- University BA degree or higher

Major:

- Engineering (preferably electromechanical)

Languages: - English (advanced)

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上海西门子医疗器械有限公司(http://www.healthcare.siemens.com.cn/about-us-cn/healthcare-development-ssme-cn)成立于1992年，是西门子（中国）有限公司下属的独资公司。目前公司致力于计算机断层扫描诊断设备(CT)、X光机诊断设备、及其零部件的研发生产。相关客户服务也是我们业务的重要组成部分。公司并参与Soarian MedSuite 的全球研发及在中国的项目实施。公司被上海市政府授予高新技术企业称号。

上海西门子医疗器械有限公司不仅是西门子供应全球市场的医疗影像设备制造基地，而且是西门子医疗影像设备和医疗软件的研发中心之一。公司拥有800多名员工，其中研发人员超过270人。

上海西门子医疗器械有限公司位于上海国际医学园区（周祝公路278号），占地面积10万平方米，其中各类研发及生产区域占地超过35000平方，总投资超过3亿多人民币，是西门子医疗业务领域在亚太地区最大的研发和制造中心，也是目前上海最大的医疗器械研发生产高科技企业之一。

近几年来，公司发展尤为迅速。 CT业务部门成功研发制造了双层螺旋CT SOMATOM Spirit，以及6层16层螺旋CT SOMATOM Emotion系列。X光机部门则成功地向市场推出了中国热销的X射线拍片系统Aristos VX Plus等优质产品。

公司的客户服务部门，提供培训，区域技术支持及各类零备件的物流服务。

公司的医疗软件部门致力于研发和实施西门子全球化和本地化的Soarian MedSuite产品

公司将继续加大研发力度，为市场提供更多高品质的医疗设备和医疗软件，为健康水准的普遍提高作出积极贡献。

公司地址：上海市浦东新区周祝公路278号 邮　　编：201318

公司网站：http://www.healthcare.siemens.com.cn/about-us-cn/healthcare-development-ssme-cn

公司邮箱：recruitment_healthcare@siemens.com