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
Job Description
Our vision for Regulatory Affairs at BD
The Regulatory Affairs team is helping to ensure speed to market for BD’s innovative medical technologies by having an acutely patient-centric attitude.
About the role
As Regulatory Affairs Director you will define, develop and lead global strategies to improve global regulatory success towards achievement of program objectives for complex projects. In this role you will ensure global regulatory plans accommodate appropriately achievement of business objectives and optimally communicates with project teams, line management and key partners on any developments that may impact regulatory success.
Main responsibilities will include:
- Provide innovative ways, strategic and tactical mentorship to resolve regulatory issues and increase speed to market
- Ensure high quality collaboration with Regional Regulatory partners by providing timely guidance and partnership in health authority meetings and regulatory documentation spanning throughout the product lifecycle
- Provides guidance on planning, writing and review of dossier documents for submissions globally
- Represent BD in interactions with health authorities for the product portfolio assigned
- Lead cross-functional stakeholder alignment to drive robust regulatory submissions
- Remains on the forefront of the relevant science and competitive landscape via actively contribution to policy shaping efforts including partnering with trade associations; viewed as an expert in its application to the regulatory process
- Coach and mentor team, create an open, inclusive environment for associates to grow and challenge themselves
About you
We are looking for experienced leader in Medical Device Regulatory Affairs with expertise in global regulatory requirements and standards applicable to medical devices (software-hardware integrated technologies, apps, cloud solutions, digital tools) e.g., ISO13485, QSR, EU MDR, US FDA – 510k and PMA.
Your attributes include:
- Knowledge of and experience in pre-market regulations including regulatory and risk management processes
- Experience in all regulatory compliance aspects of the business: pre-market, commercial, and post-market
- Excellent verbal and written communications skills.
- Strong project coordination, business acumen and negotiation abilities
- Ability to lead, develop and empower multi-cultural and multi-national teams
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
Primary Work Location
CHE Eysins - Business Park Terre-BonneAdditional Locations
Work Shift
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.