IVD Medical Device Technical Expert

This is a fully remote position, open to applicants in China.

📋 Description

• Develop, oversee, and manage a portfolio of CE marking schemes for Medical Devices, focusing on specific areas of expertise.

• Conduct technical reviews and manage schemes to support CE marking initiatives.

• Offer leadership and mentoring in Medical Device QMS assessment and provide device expertise to Healthcare professionals.

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

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

• Enhance patient safety through specialized knowledge in IVD medical devices.

⛳️ Requirements

• A Bachelor's degree or higher in a field relevant to the design, manufacture, and use of IVD medical devices, or an equivalent qualification.

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

• Familiarity with design control principles, risk management, and performance and/or clinical evaluation.

• A primary emphasis on IVD infectious diseases.

• Understanding of medical device regulations.

• Knowledge of certification business processes.

• Awareness of quality management standards and the audit process.

• Resume must be submitted in English.

• Possess analytical, communicative, diligent, and inquisitive traits.

• Willingness to travel as needed.

🏝️ Benefits

• A competitive total rewards package.

• An independent and diverse role within an international setting.

• Flexible working hours.

• Continuous training and development opportunities.