Product Safety Specialist Medical Devices
il y a 1 mois
**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.
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.
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
**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 needsin 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.
**Qualifications**:
- Advanced scientific training, master's degree in toxicology or studies in biochemistry applied to health.
- Experience in fields related to medical affairs rather than regulatory aspects.
- Target industries: cosmetic, medical, medical device, and agri-food chemistry sectors.
- Knowledge of medical industry standards (ISO10993, EU MDR)
- Good teamwork and cross-functional/cross-cultural collaboration skills.
- Ability to create and maintain a network and have good influencing skills.
- Ability to review scientific information, analyze it, and synthesize it.
- Good written and oral communication skills in English.
- Comfortable with computer tools.
This role is located in our global headquarter in Pont de Claix (Grenoble area) and offers a from home working option aligned with BD working policy.
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.
**Required Skills**:
Optional Skills
**Primary Work Location**: FRA Le Pont-de-Claix Cedex
**Additional Locations**:
**Work Shift**:
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