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
Accountabilities in this roleThis position supports execution of the Software CoE by having a thorough understanding of various data sources (i.e. requirements, security assessments, system architecture) and system and business processes (i.e. product registration, development and verification) in order to accurately and concisely assess new and existing software component changes for their impact to the entire system.
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!
Essential Responsibilities:
- Create and perform ongoing assessment of software products, both new and modified relative to their function within the system.
- Collaborate with CoE team as well as cross functional teams (project management, engineering, quality, cybersecurity) to understand product under assessment.
- Optimize the current process for change assessment, design and development and propose process improvements when applicable.
- Communicate progress and milestones for project initiatives.
Qualifications
- BA/BS required
- Software Engineering, Software Quality Engineering or related education, training and/or experience required.
- 2+ years experience in regulated environment (medical devices preferred).
- Change assessment experience specific to systems and software level changes (requirements, design) and ability to assess impact of changes within the system.
- Experience with Systems-of-Systems products i.e. interoperable systems.
- Proficient in English
- Highly strategic and analytical problem solver with solid business acumen.
- Ability to prioritize and execute a variety of objectives and clearly communicate progress and roadblocks
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
MYS Kuala Lumpur - Jalan KerinchiAdditional Locations
Work 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.