• Provide technical support to regulatory submissions in the area of biocompatibility and Hazardous Substances.
• Provide assessments of existing and new medical device product against current medical device regulations and international standards.
• Determine activities needed to remediate medical device product biocompatibility and hazardous substance data to current requirements.
• Document compliance of product to internal procedures.
• Support the quality and reliability of released product through comparative testing or root cause characterization testing.
• Participate in the analysis of technical issues and the development of recommendations for project decisions and actions
• Knowledge of materials and interactions with the body and environment
• Ability to correlate material properties with product performance and predict various failure modes
• Knowledge of international and domestic regulations associated with biocompatibility and Hazardous Substances
• Experience in a regulated industry
• Knowledge of Microsoft applications (Excel, Word, Outlook)
• Materials Science knowledge with an emphasis on materials testing, processing and analysis
• Demonstrated problem solving and critical thinking skills