IVD Technical Specialist, CE Marking & QMS (Remote)

BSI; United Kingdom; On-site; GBP 63,000 - 75,000; Full time

Job summary

BSI is seeking a Technical Specialist for IVD devices to join the team remotely with UK/EMEA coverage. You will work on CE marking schemes focused on cancer and molecular biology, contributing to patient safety and regulatory excellence.

This role combines technical reviews, scheme management, and QMS guidance, with occasional travel. A Bachelor's or higher in a related field, plus 4+ years in IVD design and regulatory practices, is required.

Qualifications

• Bachelor's degree or higher in a discipline relevant to IVD medical device design, manufacture and use.
• Post-graduate experience in the design and development of IVD medical devices, including design control, risk management, and evaluation.

Responsibilities

• Build, control and manage CE marking schemes for IVD expertise areas.
• Deliver technical reviews and scheme management to support CE marking.
• Provide Medical Device QMS assessment and device leadership to healthcare personnel.
• Provide technical sales/networking support to the commercial team.

Skills

IVD knowledge

Regulatory awareness

Communication

Education

Bachelor's degree or higher in IVD related field

Post-graduate experience in IVD design

Job description

BSI is seeking a Technical Specialist for IVD devices to join the team remotely with UK/EMEA coverage. You will work on CE marking schemes focused on cancer and molecular biology, contributing to patient safety and regulatory excellence.

This role combines technical reviews, scheme management, and QMS guidance, with occasional travel. A Bachelor's or higher in a related field, plus 4+ years in IVD design and regulatory practices, is required.