Senior Medical Device Toxicologist

Galway, IrelandOn site9 days ago

Job description

Purpose: The Senior Medical Device Toxicologist at Boston Scientific provides technical support for toxicology and biocompatibility processes to meet global business objectives. Additionally, this position is responsible for the biological evaluation of medical device… ## What you'll do - 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 ## What you'll bring . - Demonstrate a primary commitment to patient safety and product quality. - 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. - Maintains communications with internal customers on biocompatibility and toxicology issues, support problem solving and resolution related to related to biocompatibility assessments, chemical characterization, and toxicological risk assessments - Consults on biocompatibility, chemistry and toxicology testing and strategies related to new investigational and strategic device development programs during Technology and Product development programs (TDP/PDP). - 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. - May serve as a resource for biocompatibility and toxicology information for medical devices and pharmaceutical materials, which may include issues related to materials of animal origin, color additives, exposure assessments of chemicals, and other chemical toxicities. - Advises on procedures, techniques, concepts and approaches used at divisional levels for biocompatibility and toxicology programs. Education & Experience: Required qualifications: - Level 8 Hons Bachelor Degree (or higher) in Toxilocology or related discipline (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. ## Nice to have - 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. As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. …