MD Technical Specialist-Vacular Devices
英标管理体系认证（北京）有限公司
- 公司规模：150-500人
- 公司行业：检测，认证
职位信息
- 发布日期：2016-10-09
- 工作地点：北京
- 招聘人数：若干人
- 工作经验：8-9年经验
- 语言要求：英语 精通
- 职位月薪：25000-29999/月
- 职位类别：药品生产/质量管理 专业顾问
职位描述
职位描述：
Due to continuing strategic growth within our Medical Devices business, we currently have vacancies for Technical Specialists within the Vascular team. This is an excellent opportunity to join a leading Notified Body, driving up the standard of safety and performance of Medical Devices for patients across Europe, and to be involved in the evaluation of cutting edge innovation and state of the art technologies. This is a home based role in China ideally in Beijing, Shanghai and Guangdong province areas.
About the Role:
As the Technical Specialist you will be involved in the review and evaluation of your client’s medical device technical documentation and your opinion will influence which products go to market. You’ll be working with a variety of medical device manufacturers globally, managing a portfolio of product types, with a commitment to delivering a diligent and timely service.
The fast paced nature of this rewarding role will eventually require you to work autonomously with manufacturers as they execute their ‘go to market’ plans.
The role requires the Technical Specialist to be efficient and effective in; comprehending technical information, targeted questioning, forming opinions and offering recommendations. The role requires the Technical Specialist to provide a critical, but common sense, evaluation of the information provided by the manufacturer to demonstrate conformity with applicable regulations or standards.
About You:
To be successful in this role you will need to apply the significant knowledge and extensive ‘hands on’ experience that you have gained in research, design and development of medical devices, including the application of the principles of design control, risk management and performance or clinical evaluation. The right candidate will have demonstrated strong inter-personal and communication skills, as well as a track record in project or programme management. Good written and spoken English language skills are essential.
The role requires you to have extensive experience in the design, development and manufacturing of at least a few of the following Vascular Devices including, stents and stent delivery systems, percutaneous heart valves, devices to treat abdominal aortic aneurysms ablation and electrophysiology catheters, neurovascular experience (embolic coils, neurovascular stents and related accessories) and have basic experience with other cardiovascular devices such as balloon catheters, PICC or CVC catheters, guide wires, introducers, closure devices and related accessories.
You’ll also hold a BSc, Master’s degree or PhD (or equivalent qualification) in a discipline relevant to medical device manufacture and use.
What we offer:
We offer a highly competitive starting salary of CNY 25000/mnth plus 20% bonus. We pride ourselves on setting the industry benchmark and invest significantly in our teams to ensure that our people have the best possible opportunity to deliver an excellent service and progress their careers. As the successful candidate, you will embark on a comprehensive induction into the role and will be supported in a continuous professional development programme.
We pride ourselves on setting the industry benchmark and invest significantly in our teams to ensure that our people have the best possible opportunity to deliver an excellent service and progress their careers.
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Due to continuing strategic growth within our Medical Devices business, we currently have vacancies for Technical Specialists within the Vascular team. This is an excellent opportunity to join a leading Notified Body, driving up the standard of safety and performance of Medical Devices for patients across Europe, and to be involved in the evaluation of cutting edge innovation and state of the art technologies. This is a home based role in China ideally in Beijing, Shanghai and Guangdong province areas.
About the Role:
As the Technical Specialist you will be involved in the review and evaluation of your client’s medical device technical documentation and your opinion will influence which products go to market. You’ll be working with a variety of medical device manufacturers globally, managing a portfolio of product types, with a commitment to delivering a diligent and timely service.
The fast paced nature of this rewarding role will eventually require you to work autonomously with manufacturers as they execute their ‘go to market’ plans.
The role requires the Technical Specialist to be efficient and effective in; comprehending technical information, targeted questioning, forming opinions and offering recommendations. The role requires the Technical Specialist to provide a critical, but common sense, evaluation of the information provided by the manufacturer to demonstrate conformity with applicable regulations or standards.
About You:
To be successful in this role you will need to apply the significant knowledge and extensive ‘hands on’ experience that you have gained in research, design and development of medical devices, including the application of the principles of design control, risk management and performance or clinical evaluation. The right candidate will have demonstrated strong inter-personal and communication skills, as well as a track record in project or programme management. Good written and spoken English language skills are essential.
The role requires you to have extensive experience in the design, development and manufacturing of at least a few of the following Vascular Devices including, stents and stent delivery systems, percutaneous heart valves, devices to treat abdominal aortic aneurysms ablation and electrophysiology catheters, neurovascular experience (embolic coils, neurovascular stents and related accessories) and have basic experience with other cardiovascular devices such as balloon catheters, PICC or CVC catheters, guide wires, introducers, closure devices and related accessories.
You’ll also hold a BSc, Master’s degree or PhD (or equivalent qualification) in a discipline relevant to medical device manufacture and use.
What we offer:
We offer a highly competitive starting salary of CNY 25000/mnth plus 20% bonus. We pride ourselves on setting the industry benchmark and invest significantly in our teams to ensure that our people have the best possible opportunity to deliver an excellent service and progress their careers. As the successful candidate, you will embark on a comprehensive induction into the role and will be supported in a continuous professional development programme.
We pride ourselves on setting the industry benchmark and invest significantly in our teams to ensure that our people have the best possible opportunity to deliver an excellent service and progress their careers.
职能类别： 药品生产/质量管理 专业顾问
公司介绍
BSI集团是全球领先的独立的业务服务机构，成立于1901年，并于1929年获得英国皇家特许，成为世界上多个国家标准机构。百多年来，我们一直秉承公正、创新、独立的企业精神，为全球客户提供基于标准的解决方案，并连续五年获得商业超级品牌荣誉。
BSI制定并颁布了商业标准，并以每年编撰3,100个标准的优势享誉全球。 同时，作为国际标准化组织（ISO）的创始成员之一，BSI创立了全球最值得信赖和得到广泛认可的ISO系列管理体系，如今BSI已成为标准的代名词。目前被广泛运用的ISO 9000、ISO 14000、ISO 27001及OHSAS 18000均是由BSI颁布制定的BS 5750、BS 7750、BS 7799和BS 8800标准转化而来。
目前，BSI在全球分支机构已达180多家，现拥有4600多位员工，业务遍及欧洲、中东、非洲、亚洲和美洲在内的193个国家。如今，已有50％的“全球财富500强”企业和84％的“金融时报指数100强”的企业选择BSI向其提供服务。
BSI 于1995年进入中国，协助中国政府培养了中国专业审核员并建立认证制度。BSI在中国成长迅速，目前已拥有300多位员工，总部设在北京，同时在全国10多个主要城市都设有办事处和联络处，为中国客户提供专业化、职业化和差异化的服务。
BSI Introduction
Since its foundation in 1901, BSI Group has grown into a leading global independent business services organization. It was incorporated by Royal Charter in 1929 and became the first national standards institution in the world. For more than a hundred years, BSI is dedicated to the provision of standard based solutions with integrity, innovation and independence, and BSI has been independently voted a UK Business Superbrand for continuous five years.
BSI constitutes and issues the first business standard, and is famous for constituting 3,100 standards per year worldwide. As the member of International Standards Organization (ISO), BSI establishes the most reliable and acceptable ISO series management systems. The ISO 9000 quality series were developed from British Standard BS 5750, first published in 1979 and is recognized as the world’s most successful standard; adopted by more than 950,000 organizations in 175 countries. Furthermore, the most widely accepted environmental management systems standard, ISO 14001, was derived from BS 5750 and has been implemented in 148 countries.
Today BSI has registered clients in 193 counties covering Europe, Middle East, Africa, Asia and the Americas,serving them through a network of over 180 established branches across the world with over 4600 staff. Nowadays, over 50% of Fortune 500 businesses and over 84% of FTSE 100 businesses use the services of BSI.
BSI’s first presence in China was in 1995. BSI currently employs approximately more than 300 employees in China and is headquartered in Beijing with a further 10 offices spread around the country, providing special, professional and differential services to China clients.
BSI制定并颁布了商业标准，并以每年编撰3,100个标准的优势享誉全球。 同时，作为国际标准化组织（ISO）的创始成员之一，BSI创立了全球最值得信赖和得到广泛认可的ISO系列管理体系，如今BSI已成为标准的代名词。目前被广泛运用的ISO 9000、ISO 14000、ISO 27001及OHSAS 18000均是由BSI颁布制定的BS 5750、BS 7750、BS 7799和BS 8800标准转化而来。
目前，BSI在全球分支机构已达180多家，现拥有4600多位员工，业务遍及欧洲、中东、非洲、亚洲和美洲在内的193个国家。如今，已有50％的“全球财富500强”企业和84％的“金融时报指数100强”的企业选择BSI向其提供服务。
BSI 于1995年进入中国，协助中国政府培养了中国专业审核员并建立认证制度。BSI在中国成长迅速，目前已拥有300多位员工，总部设在北京，同时在全国10多个主要城市都设有办事处和联络处，为中国客户提供专业化、职业化和差异化的服务。
BSI Introduction
Since its foundation in 1901, BSI Group has grown into a leading global independent business services organization. It was incorporated by Royal Charter in 1929 and became the first national standards institution in the world. For more than a hundred years, BSI is dedicated to the provision of standard based solutions with integrity, innovation and independence, and BSI has been independently voted a UK Business Superbrand for continuous five years.
BSI constitutes and issues the first business standard, and is famous for constituting 3,100 standards per year worldwide. As the member of International Standards Organization (ISO), BSI establishes the most reliable and acceptable ISO series management systems. The ISO 9000 quality series were developed from British Standard BS 5750, first published in 1979 and is recognized as the world’s most successful standard; adopted by more than 950,000 organizations in 175 countries. Furthermore, the most widely accepted environmental management systems standard, ISO 14001, was derived from BS 5750 and has been implemented in 148 countries.
Today BSI has registered clients in 193 counties covering Europe, Middle East, Africa, Asia and the Americas,serving them through a network of over 180 established branches across the world with over 4600 staff. Nowadays, over 50% of Fortune 500 businesses and over 84% of FTSE 100 businesses use the services of BSI.
BSI’s first presence in China was in 1995. BSI currently employs approximately more than 300 employees in China and is headquartered in Beijing with a further 10 offices spread around the country, providing special, professional and differential services to China clients.
联系方式
- 公司地址：南京西路388号仙乐斯广场10楼1006室