Remote IVD Technical Specialist - CE Marking & QMS Expert

BSI; Italia; In loco; EUR 74.000 - 87.000; Tempo pieno

Descrizione del lavoro

BSI is seeking a Technical Specialist for the IVD Devices Team. This homebased role supports CE marking schemes across the EMEA/UK region with occasional travel, enabling expert regulatory guidance and scheme management.

You will build and supervise CE schemes, deliver technical reviews, and mentor healthcare staff on QMS and device expertise to ensure patient safety and compliance. The ideal candidate holds a Bachelor's degree in a relevant field, has 4+ years in IVD device design and

Competenze

• Bachelor's degree or higher in a discipline relevant to IVD design, manufacture and use, or equivalent qualification.
• At least 4 years' post-graduate experience in the design and development of IVD medical devices with emphasis on cancer and molecular biology.
• Knowledge of medical device regulations and QMS standards.
• Awareness of certification processes and audits for CE marking schemes.

Mansioni

• Build, control and manage a portfolio of CE marking schemes focused on IVD expertise.
• Deliver technical reviews and scheme management to support CE marking projects.
• Provide QMS assessment leadership and mentoring to healthcare personnel.
• Support the commercial team with technical sales/networking activities.

Conoscenze

IVD knowledge

Regulatory knowledge

QMS leadership

Technical reviews

Formazione

Bachelor's degree or higher in a relevant field

Descrizione del lavoro

BSI is seeking a Technical Specialist for the IVD Devices Team. This homebased role supports CE marking schemes across the EMEA/UK region with occasional travel, enabling expert regulatory guidance and scheme management.

You will build and supervise CE schemes, deliver technical reviews, and mentor healthcare staff on QMS and device expertise to ensure patient safety and compliance. The ideal candidate holds a Bachelor's degree in a relevant field, has 4+ years in IVD device design and