CE Technical Expert_IVD medical devices

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Job Title:   Technical Specialist and Scheme Manager - In Vitro Diagnostic Devices, Medical Devices
Reports to:  Global Head, In Vitro Diagnostic Devices - Medical Devices
Location:   China home-based

Purpose of the position:

• Build, control and manage a portfolio of Medical Device CE marking schemes focused around your area of expertise
• Deliver technical reviews, scheme management in support of the CE marking schemes
• Provide Medical Device OMS assessment and device expertise leadership and mentoring in areas of competence to Healthcare personnel
• Provide "Technical Sales/Networking" support to the commercial team

Key Responsibilities & Accountabilities:

• Deliver Medical Device CE Marking technical review, scheme management as a fully integrated member of the IVD Team
• Work with IVD team and other team leaders as required to provide assessment within area of expertise
• Provide advice and support to product specialists and scheme managers on certifications in area of expertise that may have a regulatory challenge

Key Result Areas :

• Delivery of Medical Device CE Marking technical review, scheme management for the IVD Team
• Fully compliant Notified Body with no systematic non-conformities at audit
• Delivery of all services to time and quality, with positive feedback from clients and colleagues
• Thorough, prompt reporting back from meetings with third parties and effective handling of issues that arise
• Timely handling of projects falling within area of specialism, whether performed personally or by other BSI staff under supervision
•  BSI becomes the Notified Body of first consultation by prospective clients and regulatory service providers through positive impact of BSI service level
• Personal growth in chosen area of expertise and business development support

Key Performance Indicators:

• Annual business financial KPls
•  Operational KPls
• Competent Authority Audit results
•  Medical device external training business performance  
• Internal training programme success

Knowledge and Experience:

• Thorough knowledge of the design and development of medical devices in area of experience, including the principles of design control, risk management and performance or clinical evaluation
• Thorough knowledge of Medical Device regulations, ISO 13485 and have a broad technical understanding of the medical device industry
• A good understanding of product certification concepts and principles
• A comprehensive understanding of quality systems, philosophies and principles and internal auditing principles and practices
• An understanding of BSI, its role and its approach to product certification policies
• A good understanding of the application of accreditation/designation, notified body, product and quality systems standards and requirements

Skills and Abilities:

• Conceptual and analytical thinking, efficiency and results orientation
• A team player good at relationship building internally and externally
• Broad technical understanding of client industry products
• General Knowledge of business principles and operating practices (commercial awareness).
• Ability to understand and interpret legislation

Qualifications:

• Bachelor degree, relevant to medical device manufacture and use, or equivalent qualification
• Fluent in English and native language in Chinese
• Above 8 related work experience
• Local hire only
• Good interpersonal skills, particularly communication and influencing skills
• Capable of operating with horizontal and vertical reporting lines.

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 is conducting face-to-face interviews where appropriate and possible. If you are invited to a face-to-face interview but feel more comfortable with conducting the interview virtually, please speak to a member of our recruitment team.