R&D Scientist

📋 Description Lead R&D in control/calibrator product development Integrate build/development within ISO13485 standards Apply ISO14971 for risk analysis to ensure safety/efficacy Manage Product Improvement & Build Change projects Oversee verification protocols and evaluation studies for IVD products Standardize proteins and assign serum values to targets 🎯 Requirements Degree in Science/Engineering or equivalent 3+ years in regulated medical device/manufacturing Knowledge of FDA 21CFR820, ISO13485, IVDD98/79/EC Strong statistical evaluation skills Excellent written and verbal communication Detail-oriented with good prioritization