Regulatory Affairs Specialist

hace 3 semanas


Centro, España Antal International Network A tiempo completo

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.
#J-18808-Ljbffr



  • Centro, España Cpl Healthcare A tiempo completo

    Job Title: Associate Director, Regulatory Affairs - Medical Device/Post-Market SurveillanceJob Type: Full Time, Permanent PositionLocations: Spain, Madrid – HybridRemuneration: Attractive salary and packageAn exciting opportunity to join a growing pharmaceutical company that specializes in Cancer and Supportive Care, Gastroenterology and Hepatology. Due to...


  • Centro, España Cpl Healthcare A tiempo completo

    Job Title: Associate Director, Regulatory Affairs - Medical Device/Post-Market Surveillance Job Type: Full Time, Permanent Position Locations: 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...


  • Centro, España Cpl Healthcare A tiempo completo

    Job 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...


  • Centro, España Mabxience A tiempo completo

    Overview: The Junior Manager, Regulatory Affairs CMC is responsible to provide regulatory relevant technical assistance to development teams and ensures adequacy of CMC documentation for global regulatory submissions including specific requirements for regional registration processes. The position supports and promotes all regulatory CMC tasks throughout the...

  • Energy Sourcing

    hace 1 día


    Centro, España Essity AB A tiempo completo

    Energy Sourcing & Regulatory Affairs Manager - Spain About the Role This position supports the strategy for energy procurement in Spain by sourcing energy for high-consumption sites within the framework of the global energy risk policy. You will manage regulatory issues related to energy consumption in Spain, ensuring compliance and competitiveness. We're...


  • Madrid Centro, Madrid, España Sobi group A tiempo completo

    Job SummaryWe are seeking a highly experienced Global Regulatory Affairs Lead to join our team at Sobi Group. As a key member of our organization, you will be responsible for providing strategic regulatory leadership for our rare disease therapies.Key ResponsibilitiesRegulatory Strategy Development: Develop and implement global regulatory strategies to...


  • Madrid Centro, Madrid, España Sobi group A tiempo completo

    Job SummaryWe are seeking a highly experienced Global Regulatory Affairs Lead to join our team at Sobi Group. As a key member of our organization, you will be responsible for providing strategic regulatory leadership for our rare disease therapies.Key ResponsibilitiesRegulatory Strategy Development: Develop and implement global regulatory strategies to...

  • Regulatory Manager

    hace 4 semanas


    Centro, España Parexel A tiempo completo

    When our values align, there's no limit to what we can achieve. Are you an experienced regulatory professional looking for a new opportunity? We are currently seeking a talented CMC Regulatory Manager (Regulatory Affairs Consultant) to join our dynamic team! This is a client dedicated project, and the role can be office or home based in various European...

  • Principal Biostatistician

    hace 4 semanas


    Centro, España Syneos Health, Inc. A tiempo completo

    Principal Biostatistician (Medical Affairs Required)Updated: October 1, 2024Location: Spain-Europe - ESP-Home-Based (Madrid)Job ID:24005267Remote Principal Biostatistician - Must be in NA or EMEA (Prior Medical Affairs experience is required)Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer...


  • Centro, España Precision Medicine Group A tiempo completo

    Precision for Medicine is not your typical CRO. At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients. What sets us apart is the way we integrate clinical trial execution with deep scientific...

  • Head of Market Access

    hace 4 semanas


    Centro, España PMFarma A tiempo completo

    DescripciónColoplast is a leader within Medical Technology and a truly professional and global company with over 16,000 employees around the globe. We are ambitious and successful; we are innovative, and we grow - all in the pursuit of our mission of making life easier for people with intimate healthcare needs.The jobOverall, you will be responsible for...


  • Centro, España Insud Pharma A tiempo completo

    Who 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...

  • Principal Biostatistician

    hace 2 semanas


    Centro, España Syneos Health, Inc. A tiempo completo

    Principal Biostatistician (Medical Affairs Required) Updated: October 1, 2024Location: Spain-Europe - ESP-Home-Based (Madrid)Job ID: 24005267 Remote Principal Biostatistician - Must be in NA or EMEA (Prior Medical Affairs experience is required) Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate...

  • Sr Medical Writer

    hace 4 semanas


    Centro, España Syneos Health Healthcare Careers A tiempo completo

    Syneos Health Healthcare Careers – Madrid, MadridSyneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.Our Clinical Development model brings the customer and the patient...

  • Head of Market Access

    hace 2 semanas


    Centro, España PMFarma A tiempo completo

    Descripción Coloplast is a leader within Medical Technology and a truly professional and global company with over 16,000 employees around the globe. We are ambitious and successful; we are innovative, and we grow - all in the pursuit of our mission of making life easier for people with intimate healthcare needs. The job Overall, you will be responsible for...

  • Public Affairs Director

    hace 4 semanas


    Centro, España Gilead Sciences, Inc. A tiempo completo

    Public Affairs Director - VirologyGilead 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 investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world....

  • Sr Medical Writer

    hace 2 semanas


    Centro, España Syneos Health Healthcare Careers A tiempo completo

    Syneos Health Healthcare Careers – Madrid, Madrid Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the...


  • Centro, España IQVIA A tiempo completo

    Job Overview Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and / or international regulations, standard operating procedures (SOPs), project requirements and contractual / budgetary guidelines. May also include maintenance activities. Specialized in ICF. Essential Functions Under general...

  • Public Affairs Director

    hace 2 semanas


    Centro, España Gilead Sciences, Inc. A tiempo completo

    Public Affairs Director - Virology 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 investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world....

  • Public Affairs Director

    hace 2 semanas


    Centro, España Gilead Sciences, Inc. A tiempo completo

    Public Affairs Director - Virology 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 investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world....