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Job Information

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.

Job Description

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

Customer support

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.

Required skills

  • Scientific background.

  • 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

  • English fluent

  • At ease with commonly used IT tools, expert knowledge with excel

Primary Work Location

FRA Le Pont-de-Claix Cedex

Additional Locations

Work Shift

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.

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

All applicants should complete the on-line application process. BD is committed to working with and providing reasonable accommodations to individuals with disabilities. If you require assistance or an accommodation because of a disability to participate in the application process, please call 855-BD-HELPS (855-234-3577) or email