Product Safety Specialist H/F - Becton Dickinson

Job Description Summary
We are looking for a highly skilled and experienced professional to join our team as a Medical Affairs Team Member.
In this role, you will BE responsible for representing medical affairs in project teams to ensure the safety of our products from design to manufacturing. Your expertise in product safety will BE invaluable in driving the innovation, development, and improvement of our products.

To succeed in this role, you should have a solid background in a scientific field, such as a master's degree, PhD, PharmD, or MD. You must BE familiar with Medical Device standards, such as ISO 10993. Your ability to work cross-functionally and cross-culturally, create and maintain networks, and influence others will BE crucial in this role.

If you have a strong attention to detail, excellent analytical skills, and the ability to critically review scientific information, we want to hear from you ! Fluency in English, both written and oral, is required, and proficiency in using computer tools is a must.

If you are ready to take on this exciting opportunity and contribute to the development of innovative medical products, click here to apply now !

Job Description

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 its 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.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 !

As a member of the medical team responsible for the development of new products or as a member of project teams (operations, product improvements, range extensions, etc.), the product safety specialist represents medical affairs in one of its two areas of expertise (product safety or clinical and human factors) within the project teams.

Your job Responsibilities :
- Represent the medical affairs in the product safety expertise within project teams.
- Advocate for medical affairs to ensure the safety of BDM-PS products under their responsibility.
- Develop the plan for design verification or design validation of products under their responsibility.
- Provide design inputs.
- Evaluate the needs in terms of product safety and biocompatibility in case of product or process changes.
- Propose a testing strategy (biological evaluation) that is then approved/discussed with management.
- Collaborate with the project manager and prioritize requests.
- Work cross-functionally to gather all necessary information for decision-making.
- Provide necessary support to all functions within the organization.
- Prepare required documents for which medical affairs are responsible.
- Write or review study synopses, protocols, and reports within their scope of responsibility.
- Interact with clients if necessary.
- Coordinate the proper execution of requested tests and ensure proper tracking and identification of samples.
- Ensure adherence to schedule, budget, and strategy.

Your Qualifications :
- Master's degree in toxicology or biochemistry applied to health.
- 2+ years in pharmaceutical product development.
- Experience in medical affairs, especially in cosmetics, medical devices, and agri-food chemistry.
- Knowledge of ISO 13485, design control, ISO 14971, ISO 10993, IEC 62366, and biocompatibility. (MANDATORY)
- Proficient in reviewing and synthesizing scientific information.
- Excellent English and French communication skills
- Proficient with computer tools.
- Strong teamwork and cross-cultural collaboration skills.
- Organized and able to manage multiple projects.

Required Skills

Optional Skills

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Primary Work Location
FRA Le Pont-de-Claix Cedex

Additional Locations

Work Shift

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Informations sur la fourchette salariale
€36,400 - €65,500 EUR Annuelle