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Position : Technical Specialist & Scheme Manager(Active devices)
Reports to: Technical Team Manager, Active Devices
Location: Home Based - China(北上广深渝）
Purpose of Position：
To manage a portfolio of Medical Device CE marking and UKCA clients.
Plan and deliver Technical File Assessments and Unannounced Audits in support of EC Certification
Manage client projects, acting as their primary contact and after satisfactory assessment make certification recommendations for CE certificate issue
Act as technical support to the commercial team when required
Provide in-house and external training in areas of expertise
Deliver Medical Device CE Technical File Assessment services from home office, and on-site as a fully integrated member of the Active Devices Team
Perform Unannounced visits to medical device manufacturers globally as a technical expert
Support the Commercial Team as it grows the customer base worldwide
Delivery of all services within required timescales and to a high quality
Maintaining client satisfaction whilst continuing to meet BSI’s ethical expectations
Performing in-house training
Maintain and expand competence in areas of technical expertise and Medical Devices certification
The jobholder will be a member of the Active Devices Team reporting to a Technical Team Manager, Active Devices and work as a colleague with other members of the Medical Devices Business Stream.
There is interface at all levels of management in client and regulatory organisations.
Some visits to the Japan office will be expected during training.
Some global travel is expected to perform technical assessments, unannounced visits and to attend relevant meetings and training (estimated 6-8 weeks per year).
Interpretation and applications of International and National standards for the design, manufacture and regulation of medical devices.
Understanding of Risk Management and FMEA of Electromedical Devices
Conceptual and analytical thinking, efficiency and results orientation
Ability to work independently with minimal supervision; self-motivated.
A team player good at relationship building internally and externally
Broad technical understanding of electromedical devices. Understanding of companies operating in these spaces and current industry trends.
Thorough knowledge of Medical Device regulation and Knowledge of QMS systems for medical devices would be advantageous.
8+ years of Medical Device experience in a technical capacity, preferably within product design, development and testing; manufacturing experience also advantageous.
Prefer: Research, Design and Development and Engineering (Hands on experience including Electrical, Software, Standards, Testing and Product types) experience.
Local language required and proficiency in spoken and written English.
Performance Development Review (PDR):
Specific performance objectives and measures will be set and agreed between the individual and their Line Manager each year and are reviewed
The PDR will also be used as a basis for making development and improvement plans and reaching agreement about what should be done in the future.
Our Excellence Behaviours: Client-centric, Agile, Collaborative. These three behaviours represent how we do things at BSI. They help us ensure that BSI is a great place to work and a highly successful business.
BSI制定并颁布了第一部商业标准，并以每年编撰2,000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。
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 2,000 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 129 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 2440 staff. Nowadays, over 42% of Fortune 500 businesses and over 75% of FTSE 100 businesses use the services of BSI.
BSI’s first presence in China was in 1995. BSI currently employs approximately more than 230 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.