Regulatory Affairs Manager | Conformity and Technical Manager | Site Portugal
Há 24 horas
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. Modelo de contratação Contrato: sem termo 40h semanais #J-18808-Ljbffr
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Regulatory Affairs Manager
1 semana atrás
Lisboa, Portugal Kaizen Gaming Tempo inteiro**We are Kaizen Gaming** Kaizen Gaming, the team powering Betano, is one of the biggest GameTech companies in the world, operating in 17 markets. We always aim to leverage cutting-edge technology, providing the best experience to our millions of customers who trust us for their entertainment. We are a diverse team of more than 2.700 Kaizeners, from 40+...
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Global Regulatory Affairs Manager
1 semana atrás
Lisboa, Portugal HAYS Tempo inteiroJoin an international pharmaceutical company who is looking for a Global Regulatory Affairs Manager. Your new company Excellent opportunity to join an international pharmaceutical company who is looking for a Global Regulatory Affairs Manager - Drug Product. Your new role This professional will be responsible for processing and coordination of regulatory...
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Global Regulatory Affairs Manager
1 semana atrás
Lisboa, Portugal HAYS Tempo inteiro**Your new company** Excellent opportunity to join an international pharmaceutical company who is looking for a Global Regulatory Affairs Manager - Drug Product. **Your new role** This professional will be responsible for processing and coordination of regulatory affairs, communication with authorities and other approval-related tasks within the quality...
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Quality & Regulatory Affairs | Medical Devices
1 semana atrás
lisboa, Portugal Ultra Controlo Tempo inteiro(Manufacturing Environment | MDR | ISO 13485) At Ultra Controlo , we develop engineering solutions for medicinal and industrial gases with a direct impact on safety in hospitals and industrial facilities. We are looking to strengthen our team with a Quality & Regulatory Affairs profile, with strong involvement in the manufacturing floor and in the regulatory...
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Regulatory Affairs Officer
Há 6 dias
Lisboa, Portugal Viatris Tempo inteiro1422 Mylan, Lda. At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs. Viatris empowers people worldwide to live healthier at every stage of life. We do so via: Access - Providing high quality trusted medicines regardless of...
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Regulatory and Start Up Manager, IQVIA MedTech, Portugal
3 semanas atrás
Lisboa, Portugal IQVIA LLC Tempo inteiroRegulatory and Start Up Manager, IQVIA MedTech, Portugal page is loaded## Regulatory and Start Up Manager, IQVIA MedTech, Portugallocations: Lisbon, Portugaltime type: Full timeposted on: Posted Todayjob requisition id: R1512190**Job Overview**Direct and manage the delivery of all required site activation, maintenance and regulatory activities for...
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Regulatory Affairs Analyst
3 semanas atrás
Lisboa, Portugal Greenvolt Tempo inteiroThe Analyst in Regulatory Affairs will support the monitoring, analysis, interpretation, and implementation of policy and regulatory developments affecting the energy sector. This position involves preparing analytical materials and presentations, providing regulatory insights to guide strategic decisions, and ensuring alignment with evolving EU and national...
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Regulatory Affairs Analyst
1 semana atrás
Lisboa, Portugal Greenvolt Tempo inteiroThe Analyst in Regulatory Affairs will support the monitoring, analysis, interpretation, and implementation of policy and regulatory developments affecting the energy sector. This position involves preparing analytical materials and presentations, providing regulatory insights to guide strategic decisions, and ensuring alignment with evolving EU and national...
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Regulatory Affairs Specialist
Há 24 horas
Lisboa, Portugal UltraCon Consultoria Tempo inteiroRegulatory Affairs Manager – Produtos Biológicos (Mercado Europeu) Europa | Ambiente internacional | Projeto estratégico Estamos à procura de um/a Regulatory Affairs Manager com forte experiência em produtos biológicos/bioinsumos, para atuar como parceiro estratégico da liderança e apoiar o crescimento do nosso portefólio no mercado europeu. Esta...
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Regulatory Affairs Study Start Up Specialist II
3 semanas atrás
Lisboa, Portugal CTI Clinical Trial and Consulting Services Tempo inteiroRegulatory Affairs Study Start Up Specialist II (RASSU) Join to apply for the Regulatory Affairs Study Start‑Up Specialist II (RASSU) role at CTI Clinical Trial and Consulting Services. Responsibilities - Prepare, review, and manage regulatory submissions under CTR (Clinical Trials Regulation) using CTIS. - Handle regulatory submissions for medical...