Medical Device Expert- IVD (In Vitro Diagnostic)

In this role you will support CE marking for IVD devices by managing schemes, delivering expert technical reviews, and guiding QMS and regulatory activities. You’ll mentor healthcare personnel and collaborate with the commercial team to enable compliant, safe medical devices. The position is home-based in EMEA with some travel and emphasizes patient safety and high-quality regulatory execution. Join a global standards organization that shapes trust and improves lives.

• competitive total reward package
• flexible working hours
• ongoing training and development

• Build, control and manage a portfolio of Medical Device CE marking schemes
• Deliver technical reviews and scheme management for CE marking
• Provide Medical Device QMS assessment and device expertise leadership and mentoring
• Provide Technical Sales/Networking support to the commercial team

• 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 design and development of IVD medical devices (cancer and molecular biology)
• Knowledge of medical device regulations
• Awareness of certification business processes, quality management standards, and audits

• analytical
• communicative
• diligent
• IVD medical device design and manufacture knowledge
• design control
• risk management