Conformity and Technical Manager
1 semana atrás
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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