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8 hours ago
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Full time
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Related skills

product development quality assurance statistical analysis iso 13485 ivd

📋 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
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