Faça parte de algo maior na BD. Aqui, você nos ajudará a manter nossos altos padrões de uma perspectiva regulatória em todos os níveis, com foco nas submissões. Requer atenção aguda aos detalhes, excelentes habilidades de comunicação e uma paixão para continuar aprendendo e atualizando seu conhecimento, o que o ajudaremos a fazer com oportunidades regulares de aprendizado. Aqui, você usará seu profundo conhecimento das regulamentações e requisitos da FDA, Canadá e ISO/MDD em torno de dispositivos médicos para atingir um objetivo único: Impulsionar o mundo da saúde™. Na BD, você pode fazer a verdadeira diferença de um.
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Job Description Summary
Join our team as the RA Senior Manager for the Pre-fillable Syringes Platform in our global headquarter located in Grenoble. Lead regulatory activities for new product development, ensuring compliance and cross-functional collaboration. Work closely with R&D, Quality Engineering, and Medical Affairs to develop regulatory strategies and drive innovation. Apply now to make a significant impact on our new product developments!Candidates should have a strong foundation in engineering or research and development, particularly in design control and regulatory standards.The perfect candidate would be someone who has experience as a Regulatory Affairs (RA) Specialist or Manager, or as an R&D Manager.
Job Description
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.
- Strong project management, negotiation, and communication skills.
- Extensive knowledge of U.S. medical device regulations, Good Clinical Practice standards, Good Laboratory Practice regulations, and Quality System Regulation.
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
--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!
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Primary Work Location
FRA Le Pont-de-Claix CedexAdditional Locations
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At BD, we are strongly committed to investing in our associates—their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You.
Salary or hourly rate ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates’ progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed.
The salary or hourly rate offered to a successful candidate is determined by their experience, education, and skills, as well as the labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location.
Salary Range Information
80 700,00 € - 145 300,00 € EUR AnnualPerfil de Sucesso
What makes a successful Regulatory Affairs Professional at BD? Check out the top traits we’re looking for and see if you have the right mix.
- Analítico
- Colaborativo
- Comunicador
- Persuasivo
- Solucionador de problemas
- Apresentador habilidoso
Impulsionando o mundo da saúde™
BD é uma das maiores empresas globais de tecnologia médica do mundo e está Impulsionando o mundo da saúde™ melhorando a descoberta médica, o diagnóstico e a entrega de cuidado. A BD ajuda os clientes a melhorar os resultados, reduzir custos, aumentar a eficiência, melhorar a segurança e expandir o acesso aos cuidados de saúde.