Remote IVD Technical Specialist - CE Marking & QMS

BSI; Spain (TX); On-site; USD 86,000 - 100,000; Full time

Job summary

BSI is seeking a Technical Specialist for IVD CE marking schemes, with 4+ years in IVD design and regulatory familiarity. This remote role supports the EMEA/UK region and involves travel as needed. Salary ranges are provided and country-based variations apply.

The ideal candidate will have a degree in a relevant field and deep knowledge of medical device regulations, risk management, and QMS leadership to ensure patient safety and compliance.

Qualifications

• Bachelor's degree or higher in IVD design, manufacture or related field.
• Minimum 4 years' post-graduate experience in the design/development of IVD medical devices.
• Knowledge of medical device regulations and quality management standards.
• Experience with CE marking schemes focusing on cancer and molecular biology.
• Ability to perform technical reviews and scheme management for CE marking.

Responsibilities

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

Skills

IVD design & development

CE marking knowledge

Quality Management System knowledge

Regulatory compliance

Medical device risk management

Technical reviews

Education

Bachelor's degree in a relevant field

Job description

BSI is seeking a Technical Specialist for IVD CE marking schemes, with 4+ years in IVD design and regulatory familiarity. This remote role supports the EMEA/UK region and involves travel as needed. Salary ranges are provided and country-based variations apply.

The ideal candidate will have a degree in a relevant field and deep knowledge of medical device regulations, risk management, and QMS leadership to ensure patient safety and compliance.