Regulatory Affairs Associate
2 meses atrás
O que você pode esperar da empresa
Esta posição requer uma avançada compreensão dos dispositivos médicos e seu uso, bem como uma compreensão do processo de submissão regulatória.
Como você criará impacto
- Avaliar o risco das estratégias regulatórias propostas e oferecer soluções
- Avaliar propostas de mudanças nos registros dos produtos e comunicar o impacto regulatório no Brasil
- Elaborar e manter o controle de processos de registro de produtos, renovações, alterações pós-registro, cumprimentos de exigência e solicitações de Boas Práticas de Fabricação
- Contatar responsáveis pelos produtos em outros países para solicitar a documentação necessária dos processos citados acima de acordo com a legislação sanitária vigente
- Analisar e informar o impacto das publicações em Diário Oficial tanto de registro de produtos quanto de novas legislações aplicáveis
- Participar de Consulta Públicas de novas legislações aplicáveis, de reuniões de associações das empresas e de encontros com o setor regulado
- Acompanhar os processos de Certificação INMETRO e ANATEL, desde os contatos com os organismos certificadores reconhecidos, até agendamento e realização de inspeções internacionais das fábricas dos equipamentos sob certificação compulsória;
- Efetuar e manter a regularização da empresa frente às autoridades sanitárias
- Dar o suporte regulatório necessário para a devida importação dos produtos
- Comunicação com as agências reguladoras
- Manter sistemas, bases de dados e indicadores atualizados.
- Acompanhamento e apoio ao marketing na elaboração, correção e aprovação de material promocional
O que faz você se destacar
- Fortes habilidades de escrita e comunicação
- Fortes habilidades interpessoais e atenção aos detalhes
- Capacidade de se comunicar efetivamente em vários níveis, inclusive com agências reguladoras
- Capacidade de gerenciar várias prioridades concomitantes; versatilidade, flexibilidade e vontade de trabalhar com as mudanças de prioridades
- Domínio de regulamentos pertinentes a dispositivos médicos bem como se manter atualizado acerca das novas legislações
- Capacidade de identificar o risco em estratégias regulatórias
- Habilidade de saber trabalhar em equipe, tendo proatividade e criando um bom ambiente de trabalho
- Habilidades analíticas e de negociação, além de capacidade para resolução de problemas
Seu histórico profissional
- Graduação em nível superior
- Mínimo de 2 anos de experiência em Assuntos Regulatórios.
- Experiência em submissão regulatória / Conhecimentos em legislação dos produtos para saúde.
Expectativas de viagem
Até 10%
EOE/M/F/Vet/Disability
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