Regulatory Affairs Specialist
hace 3 meses
Responsabilidades: Preparar, revisar y presentar la documentación técnica requerida para la obtención y mantenimiento de aprobaciones regulatorias (CE, MDR, FDA, etc.). Garantizar que los productos cumplan con todas las regulaciones locales e internacionales, incluyendo normativas de la Unión Europea (MDR) y otros mercados clave. Mantener relaciones con autoridades regulatorias, agencias de certificación y organismos de salud para facilitar la aprobación de productos. Mantenerse al día con los cambios en la legislación y regulaciones que puedan impactar el portafolio de productos y asesorar a los equipos internos sobre su implementación. Colaborar estrechamente con el equipo de calidad para asegurar que los sistemas de gestión de calidad (ISO 13485) se mantengan actualizados y en cumplimiento. Gestionar la creación y mantenimiento de expedientes técnicos y dossiers regulatorios, garantizando la disponibilidad de documentación precisa y actualizada. Requisitos: Licenciatura en ciencias de la salud, farmacia, biotecnología, derecho sanitario o áreas relacionadas. Mínimo de 3-5 años de experiencia en asuntos regulatorios, preferiblemente en dispositivos médicos o productos farmacéuticos. Profundo conocimiento de regulaciones europeas (MDR/IVDR), normativas internacionales y procesos de aprobación de productos. Capacidad para interactuar eficazmente con autoridades regulatorias y equipos multidisciplinarios. Fluidez en español e inglés, tanto escrito como hablado. Residencia en Madrid o disposición para relocalizarse. Ofrecemos: Oportunidad de trabajar en el desarrollo de soluciones tecnológicas de vanguardia que impactan de forma positiva en el sector de la salud. Un ambiente colaborativo y en crecimiento, con un equipo de profesionales altamente cualificados. Planes de formación continua en asuntos regulatorios y oportunidades para crecer dentro de la organización. Salario competitivo acorde al mercado, con beneficios adicionales y flexibilidad. ¿Interesado? Envía tu CV y únete a un equipo que está marcando la diferencia en la atención médica a nivel global.
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Associate Director, Regulatory Affairs
hace 3 meses
Centro, España Cpl Healthcare A tiempo completoJob Title: Associate Director, Regulatory Affairs - Medical Device/Post-Market Surveillance Job Type: Full Time, Permanent Position Location: Spain, Madrid – Hybrid Remuneration: Attractive salary and package An exciting opportunity to join a growing pharmaceutical company that specializes in Cancer and Supportive Care, Gastroenterology, and...
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Global Regulatory Affairs Lead
hace 1 mes
Centro, España Sobi group A tiempo completoStatistics show that women and underrepresented groups tend to apply to jobs only if they meet 100% of the qualifications. Sobi encourages you to change that statistic and apply. Rarely do candidates meet 100% of the qualifications. We look forward to your application! At Sobi, each person brings their unique talents to work as a team and make a...
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Global Quality Regulatory API Specialist
hace 3 meses
Centro, España Insud Pharma A tiempo completoWho we are? Today, we are a pharmaceutical group with a track record spanning over 45 years and a footprint in more than 50 countries, led by Leandro and Lucas Sigman. Our overarching goal is to improve people's health all over the world, providing accessible, effective, safe, quality medicines through our various business units, underpinned by continuous...
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Product Regulatory Specialist
hace 4 semanas
Madrid Centro, Madrid, España SGS A tiempo completoJob Title: IVDR Product AssessorWe are seeking a highly skilled and experienced IVDR Product Assessor to join our team. As an IVDR Product Assessor, you will play a critical role in ensuring the safety and effectiveness of in-vitro diagnostic medical devices for patients across Europe.Your primary responsibility will be to conduct technical file reviews...
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Compliance Specialist
hace 3 meses
Centro, España DeNexus Inc. A tiempo completoLocation: Madrid (other locations in Spanish territory can be evaluated) | Full-time Position Summary/Objective DeNexus is solving actionable cyber-risk management with our DeRISK Software as a Service (SaaS) offering to enhance the decision making of industrial operation risk owners. We are seeking a Compliance Specialist to ensure our products, services...
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Public Affairs Director
hace 4 semanas
Centro, España Gilead Sciences, Inc. A tiempo completoPublic Affairs Director - Oncology / Cell Therapy Locations: Spain - Madrid Time Type: Full Time Posted on: Vor 16 Tagen Job Requisition ID: R0042411 Job Description Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and...
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Accounting Specialist
hace 4 semanas
Madrid Centro, Madrid, España Exclusivas Imanara A tiempo completoJob Overview:We are seeking a highly skilled Accounting Specialist to join our team in Madrid. As an Accounting Specialist, you will be responsible for managing financial transactions, maintaining accurate records, and ensuring compliance with regulatory requirements.Key Responsibilities:Perform financial calculations and settle taxes (VAT, IRPF,...
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Category Specialist
hace 3 meses
Centro, España PuroClean Certified Restoration Specialist of Auburn A tiempo completoJOB PURPOSE Provide internal and external relevant information and data flow to the demand organization to ensure customer centricity and consumer driven decisions. Create and coordinate the Category Management Vision, design strategies, identify potential and initiate projects that will ensure category growth and RC market share, through the development of...
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Government and Institutional Relations
hace 3 meses
Centro, España HITACHI ENERGY SPAIN, S.A.U. A tiempo completoDescription As a Government & Institutional Relations Lead, will be part of Hitachi Energy business and reporting to the Group Senior Vice President, Global Head of Government & Institutional Relations, you are responsible to ensure compliance with external regulatory requirements and implementation of relevant internal company policies and procedures and...
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Grid Commissioning Specialist Spain
hace 4 semanas
Madrid Centro, Madrid, España Eni Deutschland GmbH A tiempo completoJob Description\We are seeking an experienced Grid Commissioning Specialist to join our team in Madrid, Spain. As a key member of our development project management and services department, you will be responsible for managing the platforms for the commissioning process and ensuring the necessary permits are obtained.\Key Responsibilities\\Develop and...
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Trading Regulations Specialist
hace 3 meses
Centro, España Galp Energia España SAU A tiempo completoGalp has been part of society for generations, and as energy changes, we adapt too. Here you will have the opportunity to grow, with the resources you need to develop at your own pace, in your own way. Together we can continue to contribute to the communities where we live and work. We can build a more efficient future for ourselves and for future...
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Clinical Diagnostic Technology Expert
hace 4 semanas
Madrid Centro, Madrid, España SGS A tiempo completoJob SummaryAs an IVDR Product Assessor at SGS, you will play a critical role in ensuring the safety and effectiveness of in-vitro diagnostic medical devices for patients across Europe. Your primary responsibility will be to conduct technical file reviews against the EU In-Vitro Diagnostics Regulation (IVDR) for Class A sterile, Class B, and Class C devices...
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In Vitro Diagnostic Device Assessor
hace 4 semanas
Madrid Centro, Madrid, España SGS A tiempo completoAbout the RoleWe are seeking a highly skilled and experienced IVDR Product Assessor to join our team. The successful candidate will play a critical role in ensuring the safety and effectiveness of in-vitro diagnostic medical devices for patients across Europe.The primary responsibility of this role will be to conduct technical file reviews against the EU...
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Category Specialist
hace 3 meses
Centro, España Mars, Incorporated and its Affiliates A tiempo completoJob Description: JOB PURPOSE Provide internal and external relevant information and data flow to the demand organization to ensure customer centricity and consumer driven decisions. Create and coordinate the Category Management Vision, design strategies, identify potential and initiate projects that will ensure category growth and RC market share, through...
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Category Specialist
hace 3 meses
Centro, España Mars (New) A tiempo completoProvide internal and external relevant information and data flow to the demand organization to ensure customer centricity and consumer driven decisions. Create and coordinate the Category Management Vision, design strategies, identify potential and initiate projects that will ensure category growth and RC market share, through the development of the optimal...
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Senior ALM Specialist
hace 1 mes
Centro, España Mirai Advisory SL A tiempo completoYour mission You will be immersed in a functional and technical training of our tool. You will also get to know first hand the work of the different technology teams to have a total picture of the product.After this training period, you will be part of an implementation and functional development team, where you will work collaboratively with the other...
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Centro, España Institut Straumann AG A tiempo completoAbout Straumann Group The Straumann Group (SIX: STMN) is a global leader in tooth replacement and orthodontic solutions that restore smiles and confidence. It unites global and international brands that stand for excellence, innovation and quality in replacement, corrective and digital dentistry, including Anthogyr, ClearCorrect, Medentika, Neodent, NUVO,...
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Senior Banker/ Director
hace 3 meses
Centro, España Page Executive A tiempo completoAbout Our Client International Bank located in Madrid. Job Description Development & Management of a new client portfolio consisting of IPP´s focusing on Corporate Banking and Project Financing. Financial Strategic Advisory to corporate clients. Leading the relationship with IPP´s in Spain and Portugal Sustainable Finance projects in Spain. Development...
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Legal Counsel Healthcare Development
hace 1 mes
Centro, España Emd PM A tiempo completoYour Role: As Legal Counsel, you will join our Healthcare’s Development & Franchises (D&F) Legal Team, reporting to the Head of Legal Healthcare for Therapeutic Area Oncology. In this role, you will serve as a subject matter expert and strategic legal partner to the Healthcare’s Global Development Operations organization. You will also collaborate...
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Compliance Case Analyst
hace 3 meses
Centro, España Crypto Directories A tiempo completoBinance is the leading global blockchain ecosystem and cryptocurrency infrastructure provider whose suite of financial products includes the world’s largest digital-asset exchange. Our mission is to accelerate cryptocurrency adoption and increase the freedom of money. If you’re looking for a fast-paced, mission-driven organization where opportunities to...