A member of the Global Toxicology and Biocompatibility Department providing support for the Boston Scientific biocompatibility and toxicology processes; offering related technical support to assigned business divisions in support of new product development, regulatory submissions and design, manufacturing, process and vendor changes to current products to meet business objectives.
Job Responsibilities:
Provides support for biocompatibility and toxicology processes initiated by department management and ensures 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.
Demonstrates a primary commitment to patient safety and product quality.
Under direction and mentorship of senior staff, completes biological evaluations and toxicology risk assessments as necessary to support divisional objectives.
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.
Serves as a resource for biocompatibility and toxicology information for medical devices and pharmaceutical materials, which may include issues related to materials of animal origin, colorant additives, exposure assessments of chemicals, and other chemical toxicities as assigned.
Communicates with internal customers on biocompatibility and toxicology issues and supports problem-solving and resolution related to chemical risk assessments and biocompatibility assessments as assigned.
Provides input on biocompatibility, chemistry and toxicology testing related to new investigational and strategic device development programs during Technology and Product development programs (TDP/PDP).
Participates in a Biocompatibility Training Program for all functional groups of device development teams based on standards and regulatory requirements.
Job Requirements:
Candidates require at least a Bachelor or Master in Toxicology is preferred or an alternative degree in chemistry, biochemistry, biology, biomedical science or a related field.
Excellent written and verbal communication skills in English.
Professional with an understanding and application of principles, theories, and concepts in the biocompatibility of medical devices; experience with ISO 10993 preferred.
Results and detail-oriented, with the ability to multi-task while working against aggressive timelines.
Comfortable in a dynamic environment and able to work independently as well as in teams.
Requires at least 2-3+ years of medical device biocompatibility experience preferable or an equivalent combination of education and experience.
Experience working with regulated authorities preferable.#J-18808-Ljbffr