Sea parte de algo más grande en BD. Aquí, nos ayudará a compartir nuestras soluciones innovadoras con más clínicas, médicos, farmacias y entidades médicas que, a su vez, beneficiarán la salud y el bienestar de las personas y los pacientes de todo el país. Es un puesto emocionante, desafiante y gratificante, pero trabajará desde una posición sólida gracias a nuestro nombre de confianza y la convicción que desarrollará rápidamente en nuestros productos . Aquí, canalizará todas sus habilidades y experiencia en ventas hacia un único objetivo: impulsando el mundo de la salud™. En BD, puede hacer una verdadera diferencia.
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Responsibilities
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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Success Profile
¿Qué hace exitoso a un Profesional de Asuntos Regulatorios en BD? Echa un vistazo a los principales rasgos que estamos buscando y mira si tienes la combinación adecuada.
- Analítico
- Colaborativo
- Comunicador
- Persuasivo
- Solucionador de problemas
- Presentador experto
Avances en el mundo de la salud™
BD es una de las compañías de tecnología médica más grandes del mundo y está mpulsando el mundo de la salud™ al mejorar el descubrimiento médico, el diagnóstico y la entrega de cuidado. BD ayuda a los clientes a mejorar los resultados, reducir los costos, aumentar la eficiencia, mejorar la seguridad y ampliar el acceso a la atención médica.