Senior Medical Device Toxicologist

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. Responsible for authoring biocompatibility and chemical characterization test plans, author Biocompatibility Assessments and Reports, and assess test data and reports as necessary to support business objectives. Responsible for advising more junior staff on the development of Biocompatibility and chemical characterization test plans, reviewing and approving Biocompatibility Assessments and Reports, and assessing test data and reports as necessary to support business objectives, including authoring such reports as necessary. Provides consultation on regulatory requirements related to medical device submissions for assigned divisions and in support of corporate initiatives. Participates as assigned in a Biocompatibility Training Program for all functional groups of device development teams based on standards and regulatory requirements. Advises on procedures, techniques, concepts and approaches used at divisional levels for biocompatibility and toxicology programs. A BS degree in Toxicology or closely related field (biology, chemistry, biochemistry, biomedical engineering). Minimum of 5 years' experience supporting medical devices. Knowledge of the biological evaluation of medical devices and / or drug-device combination products. A MS degree in Toxicology or closely related field (biology, chemistry, biochemistry, biomedical engineering). Will consider candidates with a MS and 3+ years of related experience. A PhD degree in Toxicology or related field (biology, chemistry, biochemistry, biomedical engineering). Will consider candidates with a PhD and 1+ years of related experience. Applied knowledge and understanding of toxicology principles and best practices. 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 and combination products. Experience with running GLP and nGLP 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.