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
The Regulatory Affairs Specialist for Regulatory Clearance at BDB EMEA supports registration and regulatory strategies for the BDB portfolio. This role involves regulatory support, impact assessments, and cross-functional alignment to ensure compliance and timely product registrations.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 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 amaker of possiblewith us!
Our vision forRegulatory Affairat BD
The Regulatory Affairs team is helping to ensure speed to market for BD’s innovative medical technologies by having an acutely patient-centric mindset.
About the role
The Regulatory Affairs Specialist for Regulatory Clearance at BDB EMEA reports directly to the Senior Regulatory Affairs Manager of the same division. This role supports the implementation of registration and regulatory strategies for both the BDB portfolio.
Main responsibilities will include:
- Regulatory Support:Provide regulatory support for BDB and IDS products in EMEA, focusing on timely product registrations to market.
- Regulatory Impact Assessment:Assess the impact of EU regulations (EU IVDR and EU-MDR) on product registrations in EMEA countries and ensure compliance with local regulatory requirements.
- Cross-functional Alignment:Navigate within the BD matrix organization to align regional regulatory strategies with Business Unit (BU) and Country Regulatory Affairs (RA) teams’ objectives.
- Dossier Preparation:Assemble technical information by interacting with BU RA to create Registration and/or Notification Dossiers in compliance with local requirements and support registration submissions.
- Regulatory Amendments:Process regulatory amendments and re-registrations for existing product registrations, providing timely responses through the applicable system.
- Database Maintenance:Maintain the EMEA Registration databases.
- Impact Assessments:Conduct impact assessments for product changes and/or regulation changes in EMEA to ensure compliance with legislations/regulations.
About you
- Bachelor’s degree in Life Sciences, Regulatory Affairs, or a related field. Advanced degree preferred.
- Minimum of 3-5 years of experience in regulatory affairs, preferably within the medical device or in vitro diagnostics industry.
- Experience with EU regulatory requirements, including EU IVDR and EU-MDR, is highly desirable.
- Strong understanding of regulatory processes and requirements in the EMEA region.
- Excellent organizational and project management skills.
- Ability to navigate and work effectively within a matrix organization.
- Strong communication and interpersonal skills to interact with cross-functional teams.
- Detail-oriented with strong analytical and problem-solving abilities.
- Proficiency in maintaining regulatory databases and preparing technical dossiers.
- Ability to manage multiple projects and prioritize tasks optimally
This position is open to candidates from any location within the EMEA region.
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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Primary Work Location
BEL Erembodegem - Dorp 86Additional Locations
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Perfil 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.