Medical Device Toxicologist II

Your responsibilities will include: Provide support for biocompatibility processes initiated by department management and ensure biocompatibility and toxicology related information and data are accurate, reliable, and support business objectives as consistent with Global Preclinical objectives and Quality Management System requirements. Provides input on the regulatory requirements related to medical device submissions, on procedures, techniques, concepts and approaches used at divisional levels for biocompatibility and toxicology programs. Participates as assigned in training for functional groups of device development teams based on standards and regulatory requirements. Provides input on biocompatibility, chemistry and toxicology testing related to new investigational and strategic device development programs. A BS / MS degree in Toxicology is preferred, or closely related field (biology, chemistry, biochemistry, biomedical engineering). Minimum of 2-3 years' experience supporting medical devices. Knowledge of the biological evaluation of medical devices (ISO 10993-1) preferred. Working knowledge of risk assessment methodologies, including the toxicological evaluation of medical device materials. Working knowledge of regulatory standards and global regulatory requirements with respect to medical device. Experience with running GLP and non-GLP studies. Excellent written and verbal communication skills. Results and detail-oriented. Able to multi-task while working against aggressive timelines. Comfortable in a dynamic environment and able to work independently as well as on teams. A BS / MS degree in Toxicology is preferred