Conformity and Technical Manager

1 semana atrás


Lisboa, Lisboa, Portugal Mediphacos Tempo inteiro

A Mediphacos é uma empresa com mais de 50 anos no mercado e com produtos em mais

de 60 países, dedicada ao desenvolvimento, fabrico e comercialização de dispositivos

médicos inovadores, na área da oftalmologia. Procuramos reforçar a nossa equipa em

Portugal com um Conformity and Technical Manager que lidere o processo de obtenção da

marcação CE de Dispositivos Médicos de classe IIa e IIb e assegure o cumprimento de

todos os requisitos legais e normativos aplicáveis.

Responsabilidades:

  • Gerir a vertente técnica e coordenar o processo de certificação CE de dispositivos médicos, de acordo com o Regulamento (UE) 2017/745 (MDR);
  • Dar suporte na elaboração e revisão de dossiers técnicos e documentação de conformidade;
  • Interagir com organismos notificados, autoridades competentes e parceiros externos;
  • Garantir a implementação e manutenção do sistema de gestão da qualidade (ISO 13485);
  • Exercer funções de Responsável Técnico perante o INFARMED e outras entidades reguladoras;
  • Apoiar equipas internas (RD, Produção, Marketing) em questões regulatórias e da qualidade.

Qualificações:

  • Formação superior em Engenharia Biomédica, Ciências Farmacêuticas, Biotecnologia ou área semelhante;
  • Experiência comprovada (min. 3 anos) em processos de marcação CE de classes IIa, IIb ou III;
  • Conhecimento sólido das normas MDR (2017/745) e ISO 13485;
  • Conhecimento do mercado de oftalmologia será valorizado;
  • Capacidade de gestão de projeto, planeamento e relação com entidades externas;
  • Domínio de português e inglês (escrito e falado);
  • Forte sentido de responsabilidade, rigor e autonomia.

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