Toxicologist - Medical Device Safety Specialist

**Job Description Summary**: We are the makers of possible

BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

BD Medical - Pharmaceutical Systems provides industry-leading needle technologies, prefillable syringes, safety and shielding systems, and self-injection systems for pharmaceutical and biotech companies across the globe. The teams offer an extensive selection of solutions designed to protect, package and deliver drug therapies. Billions of products are manufactured by our 7 global factories each year.

Reporting to the Associate Director, Medical and Scientific Affairs, we’re looking for a Toxicologist who will lead development and implementation of the Medical Affairs strategy on Safety side for our prefillable syringes product platform.

This is a key role in our organization to support our clients by providing product safety & toxicology data which may be leveraged for official filing submissions and for meetings with regulatory agencies. You will be able to collaborate with customers from the pharmaceutical industry or the notified bodies and Health authorities on biological evaluation topics.

You will also provide responses on product safety requests either internally or externally, including risk assessment during product development, defining the product use conditions, and/or performing analyses or literature review for risk characterization.

As Senior member of the team you will provide mentoring for newcomers as well as junior members of Safety team on biocompatibility/toxicology topics

**Main Responsibilities**
- Within a cross functional team involved in product development, own product safety from conception to post market for a family of product: creating the preclinical / biological evaluation strategy, executing on this strategy and delivering final toxicological risk assessments.
- Gather necessary information to document toxicological risk assessments (including literature searches).
- In collaboration with Product Safety Leader and Corporate Preclinical Development & Toxicology, ensure biocompatibility and chemical characterization studies follow the most recent regulatory requirements.
- Contribute to the improvement of the process for product safety assessment, share toxicological experience within the team and eventually bring your medicinal drug knowledge to the larger Medical Affairs’ team.

**Who are you?**
- Scientific background in biology and/or chemistry (PhD, PharmD..) with research experience ideally in a scientific field.
- Experience in toxicology with preferably a board certification in toxicology (DABT, ERT)
- Ideally familiar with the ISO10993 standard series and common materials of concern regulations (US, EU, Asia)
- Knowledge and experience in risk management activities, knowledge in medical device, combination product and/or pharmaceuticals regulatory environments (Design control, EU-MDR, ICH, GLP, GMP, REACH, ISO14971, pharmacopeias)
- Excellent communication skills to be able to translate technology and science into the business and position this to drive strategic decisions.
- Curiosity, ability to solve complex problems as well as understand the bigger picture, and navigate uncertainty. Influencing and networking skills are essential.
- Ability to work in a matrix environment within cross functional multicultural teams.
- Customer focus and ability to understand customer needs.
- Ability to be agile & nimble to changing business conditions.
- Strong collaboration and teamwork across functional groups to contribute to a productive work culture.
- Fluency in English is required, French is a plus

**Why Join Us?**

A career at BD means learning and working alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. You will have the opportunity to help shape the trajectory of BD while leaving a legacy at the same time.

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow and thrive. And find satisfaction in doing your part to make the world a better place.

Become a maker of possible with us

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 s