BD (Becton, Dickinson and Company) Product Safety Specialist in Le Pont-de-Claix Cedex, France
Job Description Summary
In charge of biocompatibility statements and documentation in all BDMPS internal and external communication.
Role and Responsibilities
Product safety standards and internal documentation
He/she is the expert with regards to standards applicable in the scope of product safety. Among those: ISO10993, Regional pharmacopeias and requirements (USP, EP, YBB, JP, JBB…), Materials of Concern related requirements (EU-MDR, REACH, ICH…). As such he/she sits at the external standard management committee to represent product safety. He/She assesses impact of standard changes on our data/files in close link with the appropriate experts (chemistry, biology…) and ensures appropriate follow up plans are defined.
He/She is owning the strategy for appropriately documenting all product safety information in BDMPS internal documentation (regulatory files, inputs to design, conclusions of design verification…). As such he/she provides guidance and drives alignment cross functionally (RA, QA, R&D… ).
He/She approves the relevant documentation when ISO10993 or product safety related standards are referenced.
In close link with product safety core team members, he/she is responsible for maintaining alignment within the database of product safety data
She/He is responsible to deliver ISO10993 statements to customers upon request via the product safety request process.
She/He is the owner of the ISO10993 statement process and continuous improvement of this process.
She/He is responding customer requests in the scope of her/his area of responsibility and expertise.
Scientific/technical writing. Excellent written and verbal communication skills
Trained and experienced with ISO10993 standard and biological evaluation processes.
Knowledge in regulatory pharma/medical device environment (GLP, GMP, pharmacopeia, design control…)
Critical thinking, able to conduct rigorous analysis, attention to detail, organized, skills in project management, willing to improve, able to deal with ambiguity
Ability to grasp complexity, multitask and track multiple projects at various stages
Ability to speak up and influence others
Ability to work cross functionally, team player
Analytical mind, proactive
Curiosity outside of own field of knowledge (biology/ chemistry/ manufacturing process/organization / material science…)
Technology watch : keep up to date information on evolution in the field of expertise
At ease with commonly used IT tools, expert knowledge with excel
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.