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
We are the makers of possibleBD 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!
Job Description
This is a fixed-term contract (1.2 year) with potential possibility to extend the contract.
Main responsibilities will include:
Creating, submitting, and maintaining product notifications in Czech Republic and Slovakia
Reviewing and approving documents required for product notifications
Maintaining up to date metrics with product releases completed
Tracking regulations applicable for medical devices and medical devices for in vitro diagnostic in Czech Republic and Slovakia
Reviewing and approving advertising / promotional materials for BD products in Veeva Vault to ensure compliance with local and corporate requirements; maintaining up to date metrics
Providing requested documents to the customers
Providing support to marketing and tenders in responding to technical questions
Collaboration with regional RA teams, using internal systems as applicable, to obtain strategic alignment for product launches and releases as required and circulating approved strategic alignment to commercial team
Inputting and maintaining data, including licenses and registration records in internal regulatory database(s)
Supporting the EMEA Regulatory Affairs team, if required
Ensuring that Competent Authority communications regarding regulatory issues are responded to in a timely manner
Taking care for reimbursement activities and reimbursement-related local regulations
Duties / Accountibilities:
Successful execution of strategic alignment process in Czech Republic and Slovakia for BD products
Successful approval and maintenance of product notifications / notifications of change
Promotional materials review and approval
Keeping up to date RA databases per corporate, regional and local requirements
About you
Degree, preferably in a scientific discipline
1-3 years RA experience in medical devices / medical devices for in vitro diagnostic or pharmaceuticals or life science- related
Advanced English, ideally good command of Czech language
Self-motivated, comfortable with working with people remotely, thus good communication skills, both oral and written, are needed
Organized, analytical thinker with attention to details
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
CZE Praha - Na hrebenechAdditional 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.