Sterilization Medical Devices Technical Assessor

Job Summary

A company is looking for a Sterilization Medical Devices Technical Assessor.

Key Responsibilities:

• Assess and review client's technical documentation against the Medical Device Regulation
• Interact with customers to develop accurate reports of compliance
• Analyze complex regulatory requirements and determine appropriate actions

Qualifications:

• University or technical college degree in relevant fields such as Biomedical Engineering, Chemistry, or Medicine
• Minimum 4 years of 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 sterilization processes and various medical device categories
• Knowledge of medical device management systems and standards
• Experience with Risk Management (EN ISO 14971)