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