Biocompatibility Scientist

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