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
An excellent opportunity for a Regulatory Affairs Specialist in Egypt. The role will be responsible for all RA activities in the region.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!
As a Regulatory Affairs Specialist, you will be responsible for launching of Medical Device & In-Vitro Diagnostic products in the Egyptian market in addition to facilitating the importation of shipments and ensuring the absence of any regulatory issue in alignment with company standards and country regulations.
Main responsibilities will include
- Submission of registration for key launches for medical devices (MDs) and in-vitro diagnostics (IVDs) as well as following up closely until license issuance
- Managing regulatory lifecycle product management through re-registration, renewal, and variation Submission on time as required.
- Clearance support to distributors by providing all required documentation for importation.
- Updating RIM, tracking sheets, and monthly reports to reflect work in progress in an organized fashion.
- Responding to Notifications of Change (NOCs) & Impact Assessments (IAs) with clear responses on time.
- Tender support to commercial teams & distributors.
- Providing regular support, feedback, status updates and coordination related to Egypt for all Business Units to related internal and external stakeholders.
- Working closely with regulatory affairs internal affiliates to capture the existing and upcoming regulatory expectations and take appropriate actions.
- Managing storage facility and tracking of samples as per the local guidelines
- Having a solid communication with the Egyptian Drug Authority regulators while having a deep understanding of the local regulations, guidelines, and processes.
- Developing a close partnership with local business and distributors for coordinating regulatory activities with their teams
- Close & efficient follow up with EDA reviewers.
About you
- Bachelor’s (B.Sc.) Degree in Medical Field, preferably in Pharmaceutical Sciences
- 2-3 years in the Regulatory Affairs, preferably in the Medical Devices Sector
- Proficiency in spoken and written English and Arabic. French is a plus.
- Attention to details and very good organizational skills.
- High sense of urgency and ownership.
- Excellent communication and presentation skills.
- Successful history in prioritizing multiple projects, scheduling activities as well as managing tight deadlines
- Great teammate, agile, and demonstrating resilient attitude
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
Required Skills
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Primary Work Location
EGY - CairoAdditional Locations
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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.