Provides support for biocompatibility and toxicology 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.
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.
Qualifications
Candidate require to process at least Bachelor or Master in Toxicology is preferred or an alternatively chemistry, biochemistry, biology, biomedical science or a related field degree qualification.
English; excellent written and verbal communication skills.
Professional with an understanding and application of principle, theories, and concepts in the biocompatibility of medical devices; experience with ISO 10993 preferred.
Results and detail-oriented, and ability to multi-task while working against aggressive timelines.
Comfortable in a dynamic environment and able to work independently as well as on teams.
2-3+ years medical device biocompatibility experience preferable or an equivalent combination of education and experience.
Experience working with regulated authorities preferable.
