BD (Becton, Dickinson and Company) Toxicologist / ISO10993 specialist in Le Pont, France
Job Description Summary
He/She contributes to sustain a scientific culture focusing on product safety as well as health risk prevention related to subject/customer exposure to BD Medical Pharmaceutical Systems products and services. He/she provides inputs throughout product life cycle.
He/She has a strong expertise in biological, chemical and material sciences in general, with a strong emphasis on toxicology, risk management and product safety.
He/She contributes to the effective implementation, update and continuous improvement of the Product Safety related processes.
Role and Responsibilities
Product development activities
He/She provides support to medical affairs core team members with regards to product safety related topics (ISO10993 including extractable assessment, ISO14971, non clinical studies, review of project deliverables when required…). He/She provides support to product development teams as required.
Product safety role in product development:
He/She ensures that appropriate information is gathered for all products in development to conduct the biological evaluation according to ISO10993: He/she is providing support for issuing toxicology and biocompatibility review for all BDMPS products. He/She ensures that all required preclinical testing evaluating product safety are conducted in compliance with applicable standards, guidances and regulation, and according to Good Laboratory Practices and in conformity with product non clinical & clinical development plans.
He/She is responsible to maintain updated summary of all product safety testing and form general conclusion on possible residual toxicological/biocompatibility risks according to product intended uses for all BDMPS products in close link with the risk management procedure.
Product life cycle management activities
In the scope of the product safety request process, he/she is providing responses either internally or externally as required. This includes medical / safety inputs to customer complaints, support to regulatory affairs on our files, responses to customer/authorities requests (ISO10993, ISO14971, USP, ICH….), continuous improvement actions, evaluation of the impact of CAPA, deviations on patient/end user safety, impact of new regulations ….
He/She ensures all Health and Hazard Risk Evaluations / Health and Hazard Evaluations are prepared according relevant procedures and prepares these documents in close link with BDMPS MA director and CPDT.
PhD with strong skills in biology and chemistry.
Specific diploma/certification in toxicology, ERT or DABT.
Experience in chemical risk assessment (extractable).
Trained to ISO10993 standard
Curiosity outside of own field of knowledge
knowledge in medical device and pharmaceuticals industry (design control, ICH, GLP, GMP, REACH, ISO14971, USP …)
Excellent written and verbal communication skills in English
Critical thinking, able to conduct rigorous analysis, understanding of others needs
Primary Work Location
FRA Le Pont-de-Claix Cedex
BD is a leading global medical technology company that creates medical technology, devices and laboratory equipment for a variety of needs across the healthcare continuum. At BD, we are looking for candidates who possess passion, innovative solutions and a commitment to our one mission of improving access to groundbreaking medical and biotechnology services for people near and far, delivering state-of-the-art technology and cutting-edge research in the battle to fight and cure infectious diseases. With a global reach that extends across 50 countries worldwide, our network of professionals collaborates on effective measures to deliver enhanced patient quality such as lower health care delivery costs, improved health care and safety, and expanded health care for all. Join our company and see how you can become a part of one global mission to make a difference in human health.