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
In this role, the Regulatory Affairs Specialist will be working with BD’s latest technologies across a broad portfolio of products which includes Programmable Electrical Medical Devices, stand-alone software as medical device, and disposable infusion sets. This is a highly visible role within the organisation, and you will participate in cross-functional teams as the regulatory expert (e.g. new product development projects, sustaining engineering projects, MDR compliance program, etc).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 a maker of possible with us!
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 mindset.
About the role
The Regulatory Affairs Specialist will be working with BD’s latest technologies across a broad portfolio of products which includes Programmable Electrical Medical Devices, stand-alone software as medical device, and disposable infusion sets. This is a highly visible role within the organisation, and you will participate in cross-functional teams as the regulatory expert (e.g. new product development projects, sustaining engineering projects, MDR compliance program, etc).
Responsibilities:
- Compiles and communicates regulatory requirements (e.g. MDD / MDR, standards, etc.) to cross-functional groups concisely and precisely.
- Prepares and presents gap analysis assessments of regulations and guidance to peers and cross-functional groups concisely and precisely.
- Reviews and approves project documentation (design reports, labelling, etc.).
- Prepares regulatory submissions.
- Prepares and maintains regulatory files
- Represents the regulatory function in NPD and sustaining projects
Preferred Requirements:
- Hold a relevant degree (BSC in Electronics or Biomedical engineering field), or equivalent proven experience.
- 3+ years’ experience in a similar position, Medical Device is an advantage.
- Experience with regulatory submissions and exposure to programmable electrical equipment is an advantage.
- Knowledge and experience on EU MDR and standards (ISO 13485, ISO 14971 and IEC 60601 series…).
- Knowledge of FDA and international regulatory requirements is a plus.
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
IRL Limerick - CastletroyAdditional Locations
GBR Winnersh - Eskdale RoadWork Shift
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.