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Über
Review and approve protocols, reports, and compliance documents related to Research and Development activities Lead efforts to resolve product quality issues and analyze post-market data for improvement recommendations Oversee Computer System Validation activities and ensure compliance with FDA regulations and ISO standards
Required qualifications
Bachelor's degree in engineering or a related field with 2-4 years of experience in the medical device or regulated industry Expert understanding of global medical device regulations, including ISO 13485 and 21 CFR 820 Knowledge of Risk Management (ISO 14971), Biocompatibility (ISO 10993), and Sterilization standards (ISO 11135 & ISO 11137) Familiarity with IEC 60601 and automated testing tools Demonstrated competency in project management and effective communication skills
Sprachkenntnisse
- English
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