BSI
1001 - 5000 employees
Founded 1901
đź Consulting
đď¸ Construction
đŚ Logistics
Consulting ⢠Construction ⢠Logistics
BSI is a global Standards organization committed to helping organizations improve their performance and ensure safety, quality, and sustainability. As the UK National Standards Body, BSI provides a wide range of services, including certification, training, and assessment across various sectors such as healthcare, construction, and energy. BSI empowers businesses to adopt best practices and drive positive change through robust standards development and innovative solutions for a resilient digital future.
IVD Medical Device Technical Expert
đĽ 6 minutes ago
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BSI
1001 - 5000 employees
Founded 1901
đź Consulting
đď¸ Construction
đŚ Logistics
Consulting ⢠Construction ⢠Logistics
BSI is a global Standards organization committed to helping organizations improve their performance and ensure safety, quality, and sustainability. As the UK National Standards Body, BSI provides a wide range of services, including certification, training, and assessment across various sectors such as healthcare, construction, and energy. BSI empowers businesses to adopt best practices and drive positive change through robust standards development and innovative solutions for a resilient digital future.
đ Description
⢠Build, control and manage a portfolio of Medical Device CE marking schemes focused around the area of expertise ⢠Deliver technical reviews and scheme management in support of CE marking schemes ⢠Provide Medical Device QMS assessment and device expertise leadership and mentoring to Healthcare personnel ⢠Provide technical sales/networking support to the commercial team ⢠Work as a Technical Specialist and Scheme Manager for CE Marking clients ⢠Support patient safety through expertise in IVD medical devices
đŻ Requirements
⢠Bachelor's degree or higher in a discipline relevant to IVD medical device design, manufacture and use, or equivalent qualification ⢠At least 4 years' post-graduate experience in the design and development of IVD medical devices ⢠Experience with principles of design control, risk management, and performance and/or clinical evaluation ⢠Primary focus on IVD infectious diseases ⢠Knowledge of medical device regulations ⢠Awareness of certification business processes ⢠Knowledge of quality management standards and audits ⢠CV must be submitted in English ⢠Analytical, communicative, diligent, and curious characteristics ⢠Willingness to travel as required
đď¸ Benefits
⢠Competitive total reward package ⢠Independent and varied job in an international environment ⢠Flexible working hours ⢠Ongoing training and development
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