Regulatory Affairs Associate

2 meses atrás


São Paulo, Brasil Zimmer Biomet Tempo inteiro
Zimmer Biomet is a global medical technology leader. Our team members are part of a company with a heritage of leadership, a focus on shaping the future, and a mission dedicated to alleviating pain and improving the quality of life for people around the world.

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
Esta não é uma lista completa de Deveres e Responsabilidades e pode não compreender necessariamente todas as funções essenciais da função.

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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