Senior Scientist, I: Biocompatibility

Required

• Assist the biocompatibility team in development of functional training initiatives.
• Create a recurring training schedule for biocompatibility and change control
• Bachelor’s Degree in Life Science or related field with minimal 10 years of experience in a scientific role in the medical device or pharma industry OR Master’s degree (with thesis) in Life Science or related field with at least 8 years of experience in a scientific role in the medical device or pharma industry.
• Medical device, pharmaceutical or related experience or experience in a regulated environment with a proven record of success supporting marketed products is preferred, including change control processes
• Significant experience and knowledge of medical devices and combination product regulations
• Strong technical writing and verbal communication skills; ability to communicate complex technical information in a clear and easy-to-understand way (both verbally and in writing).
• Strong training and education experience
• Knowledge of ISO-10993 Standards, FDA Guidance and Regulations, and Animal Welfare Regulations.
• Demonstrate critical thinking and problem-solving skills, including analysis and presentation of data.
• Highly self-motivated and proactive; ability to execute with minimal supervision and direction. Can work independently or part of a team.
• Author internal documentation, including procedures and work instructions.
• Knowledge of Good Documentation Practices, maintain accurate documentation & related record retention documentation.