Biocompatibility Scientist

Job Summary

A company is looking for a Scientist III.

Key Responsibilities:

• Serve as Subject Matter Expert for ISO-10993 assessment management, including design and execution of biocompatibility evaluation strategies
• Create detailed Project Plans with scientific strategies and timelines, and manage experimental studies for safety characterization
• Maintain knowledge of medical device regulations and prepare technical presentations for stakeholders

Required Qualifications:

• Bachelor's Degree in Life Science/Biomedical Engineering or related field with a minimum of 6 years of experience, or a Master's degree with at least 4 years of experience
• Significant experience with medical device and combination product regulations
• Experience managing outsourced contract research activities
• Strong knowledge of ISO-10993 Standards and FDA Guidance
• Understanding of change control and quality systems for on-market products