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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Tipo:
Em tempo integral -
Trabalho Nível:
Sênior -
Viagem:
Varia -
Salário:
Competitivo -
Responsabilidades
Job Description Summary
Job Description
Key Responsibilities:
• Gather documents to assist with submission preparation dossier compilation in collaboration with senior RA team member.
• Maintain proper records in the Module Change Request and JDE system to comply with local and company regulatory and quality requirements.
• Assist in the gathering of information and research required by RA team.
• Assist in the gathering of information and research used to provide guidance and feedback to team on registration requirements for new and renewal registrations, product and process changes.
• Other incidental duties assigned by Leadership
Education and Experience:
- Bachelor's Degree in related field, min 5 years experience previous related experience Required or
- Other: in Scientific discipline (e.g., medical, pharma, Biology, Microbiology, Chemistry) Experience in preparing domestic and international product submissions Preferred
- Other: Coursework, seminars, and/or other formal government and/or trade association training Preferred
Additional Skills:
• Proven expertise in Microsoft Office Suite including Word, PowerPoint and Excel
• Good written and verbal communication skills and interpersonal relationship skills
• Good problem-solving, organizational, analytical and critical thinking skills
• Good knowledge and understanding of global regulations relevant to medical devices, Class II and/or Class III devices
• Goood knowledge and understanding of global regulatory requirements for new products or product changes
• Strict attention to detail
• Ability to interact professionally with all organizational levels
• Ability to manage competing priorities in a fast paced environment
• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
Required Skills
Optional Skills
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Primary Work Location
KOR South Korea - Seoul HQAdditional 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.