In Office, Le, Pont-de-Claix, Auvergne-Rhône-Alpes

Job Description Summary

Job Description

BD Medical - Pharmaceutical Systems PS 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.

About the Role : Reporting to the Sr. Director of Regulatory Affairs, you will lead the RA team for pre-fillable syringes new product development projects. Your main focus will be on regulatory activities, ensuring compliance with standards related to new product design.

Your Key Responsibilities :

• Lead the RA team, ensuring effective cross-functional collaboration and support throughout product development, including design control.

• Develop and implement regulatory strategies to ensure new products meet the latest regulatory requirements.

• Review promotional materials and ensure alignment with regulatory requirements.

• Educate cross-functional teams on EU and FDA requirements.

• Manage registrations with Competent Authorities and develop response strategies for regulatory questions.

About You :

• Experience in regulatory affairs and R&D within the pharmaceutical and medical device industries, with expertise in drug-device combination products.
• Engineering or Expertise in R&D : Candidates should have a strong foundation in engineering or research and development, particularly in design control and regulatory standards.
• Proven track record in regulatory standards, submission dossier preparation , and interactions with regulatory authorities.
• Extensive knowledge of U.S. medical device regulations , Good Clinical Practice standards, Good Laboratory Practice regulations, and Quality System Regulation.
• Team management proven record experience ideal
• Strong project management, negotiation, and communication skills.

Click on apply if this sounds like you!

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.

To learn more about BD visit: https://bd.com/careers

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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.

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