Non Active Medical Device Assessor

Job Summary

A company is looking for a Technical Assessor for Non-Active Medical Devices.

Key Responsibilities:

• Conduct product reviews of client technical documentation in accordance with the Medical Device Regulation
• Interact with customers to develop accurate reports of compliance or implementation of technical documentation
• Analyze regulatory requirements and make determinations of the proper course of action

Required Qualifications:

• University or technical college degree in a relevant field such as Biomedical Engineering, Mechanical Engineering, or Chemistry
• Minimum of 4 years of work experience in the medical device industry, with at least 2 years in design, manufacturing, testing, or use of the device
• Specific hands-on experience with medical devices falling within specified categories
• Knowledge of medical device management systems and standards
• Experience with Risk Management (EN ISO 14971)