Medical Device Expert – IVD, In Vitro Diagnostic

This is a fully remote position, open to applicants in United Kingdom, +4 more countries.

📋 Description

• Develop, oversee, and manage a portfolio of CE marking schemes for Medical Devices, concentrating on your area of expertise.

• Conduct technical reviews and scheme management to support CE marking initiatives.

• Offer expertise in Medical Device Quality Management System (QMS) assessments and provide leadership and mentoring to Healthcare professionals.

• Deliver technical sales assistance and networking support to the commercial team.

• Act as a Technical Specialist and Scheme Manager for CE Marking clients.

• Share your knowledge in the design and manufacturing of IVD cancer and molecular biology devices.

⛳️ Requirements

• A Bachelor’s degree or higher in a field pertinent to IVD medical device design, manufacturing, and application, or an equivalent qualification.

• A minimum of 4 years of post-graduate experience in the design and development of IVD medical devices.

• Proficiency in design control, risk management, and performance and/or clinical evaluation.

• A primary focus on IVD cancer and molecular biology.

• Familiarity with medical device regulations.

• Understanding of certification business processes.

• Knowledge of quality management standards and audit applications.

• Curriculum Vitae must be submitted in English.

🏝️ Benefits

• Position available for home-based or remote work.

• Travel opportunities.

• Chance to develop, grow, and engage with BSI’s global organization.

• Reasonable accommodations provided throughout the recruiting process.

• Purpose-driven work that positively impacts people's health, safety, and wellbeing.

• Opportunity to work across diverse industries worldwide.