Trabajos aemps en Sant Just DesvernCrear alertas

ppWe are a healthtech company specialized in the development of advanced robotic surgery systems for high-precision minimally invasive procedures. Founded in 2012 as a spin-off from UPC and IBEC, our mission is to make robot-assisted surgery more accessible, precise, and efficient worldwide. We design and develop next-generation computer-controlled surgical robotic systems and endoscopic instruments. /ppAs a bRegulatory Affairs Specialist /b, you will play a key role in ensuring our medical robotic systems comply with international regulatory requirements throughout the product lifecycle. You will work closely with Quality, Medical Affairs, RD teams to define regulatory strategies, prepare technical documentation and support the successful approval of our products in Europe, the United States and other international markets. /pulliDefine and execute regulatory strategies to support product registrations in Europe, the US and other international markets. /liliPrepare, maintain and manage Technical Documentation for medical device approvals under MDR, FDA and other applicable regulatory frameworks. /liliAnalyze regulatory requirements from authorities and Notified Bodies (e.g. MDR, FDA, AEMPS and other international agencies). /liliAct as the main point of contact with Notified Bodies, Competent Authorities and regulatory agencies throughout product approval processes. /liliParticipate in regulatory audits and inspections. /liliPrepare and maintain Clinical Evaluation Plans (CEP), Clinical Evaluation Reports (CER) and support Biological Evaluation Reports (BER). /liliConduct literature reviews to maintain up-to-date state-of-the-art evidence. /liliSupport vigilance and Post-Market Surveillance (PMS) activities. /liliMonitor regulatory changes, standards and guidance documents, performing gap analyses when required. /liliAssess the regulatory impact of changes to suppliers, manufacturing processes and products, determining whether submissions to regulatory authorities are required. /liliReview and approve regulatory aspects of commercial materials, including brochures and website content. /liliPromote a strong quality culture focused on compliance and continuous improvement. /li /ulh3What are we looking for? /h3ulliBachelor's degree in Health Sciences, Biomedical Engineering, Pharmacy, Biology, Chemistry, Engineering or another relevant scientific discipline. /lilibAt least /b b6 years of experience in Regulatory Affairs within the Medical Device industry. /b /liliExperience preparing Technical Documentation for medical devices. /liliKnowledge of European Medical Device Regulation (MDR 2017/745). /liliExperience interacting with Notified Bodies and Competent Authorities is highly valued. /liliExperience with FDA regulatory pathways (510(k), De Novo) is considered a strong advantage. /liliPrevious experience in the surgical robotics industry will be considered a strong asset. /liliStrong understanding of medical device regulations, standards and regulatory guidance. /liliKnowledge of MDR 2017/745, RD 192/2023 and relevant standards such as ISO 13485, ISO 14971, ISO 14155, ISO 10993, ISO 11607, ISO 11135, IEC 60601 and related MDCG/FDA guidance documents. /liliExcellent analytical and problem-solving skills. /liliStrong attention to detail and documentation skills. /liliAbility to interpret complex regulations and translate them into practical actions. /liliProactive, organized and collaborative mindset. /liliExcellent communication and stakeholder management skills. /liliProfessional proficiency in English. /liliFluent Spanish (written and spoken). /liliAdvanced Microsoft Office skills and experience working with ERP systems. /li /ulh3What do we offer? /h3ulliCompetitive salary aligned with experience. /liliHighly innovative environment with real impact on patients' lives. /liliOpportunity to work on cutting‑edge surgical robotic systems in an international and multidisciplinary team. /liliContinuous learning and professional development in one of the fastest-growing sectors in MedTech. /li /ul /p #J-18808-Ljbffr

¿Quieres impulsar tu carrera en Regulatory Affairs con foco en LATAM? En este rol te encargarás de gestionar expedientes regulatorios, preparar documentación técnica y coordinar estrategias de registro en diferentes países, en un entorno dinámico y de alcance internacional. Es esencial asegurarse de que cumple con los requisitos como solicitante para este puesto; por favor, lea atentamente la información a continuación. ¿Qué harás? • Realizarás y gestionarás la documentación técnica de los expedientes de registro, propios o de licencia, tanto para nuevos registros como para su mantenimiento (variaciones y renovaciones) en países de Centroamérica y LATAM., • Prepararás y gestionarás la documentación técnica de los expedientes de productos OTC en LATAM., • Planificarás y crearás la estrategia regulatoria tanto para nuevos registros como para los cambios solicitados (variaciones de registro)., • Llevarás a cabo tareas como realizar las notificaciones de exportación ante la AEMPS., • Solicitarás CPPs. ¿A quién buscamos? • Tienes el Grado en Farmacia o afín., • Tu experiencia es de al menos tres años como Técnico/a de Registros en la industria farmacéutica y has trabajado como Técnico/a Responsable., • Tu nivel de inglés es B2 o superior., • Se valorará favorablemente si dispones de experiencia trabajando con LATAM. ¿Qué ofrecemos? • Jornada laboral completa de lunes a jueves y viernes intensivo., • Salario competitivo., • Flexibilidad horaria de entrada y salida., • Modalidad de trabajo híbrida. xcskxlj, • Beneficios sociales. #J-18808-Ljbffr

u003cdivu003eReference: 1126360u003c/divu003eu003cdivu003eJob ID: 5398606u003c/divu003eu003cdivu003ePosted: 2026-06-10u003c/divu003eu003cdivu003eClosing date: 2026-09-08u003c/divu003eu003cdivu003eLocation: Barcelonau003c/divu003eu003cdivu003eSalary: A valorar según experiencia (per annum)u003c/divu003eu003cdivu003eJob type: Permanentu003c/divu003eu003cdivu003eIndustry: Farmacéutica / Pharmau003c/divu003eu003cdivu003eCompany: Haysu003c/divu003eu003cdivu003eConsultant: Maria Claveriau003c/divu003eu003cdivu003eHays office: Barcelona — Hays Barcelona, Calle Valencia, 307-313, bajos 1ªu003c/divu003eu003cdivu003ePhone: 664734212u003c/divu003eu003cdivu003eEmail: maria.claveria@hays.esu003c/divu003eu003cdivu003eu003cstrongu003eDescripción de la posiciónu003c/strongu003eu003c/divu003eu003cdivu003eBuscamos un/a Regulatory Affairs Specialist para incorporarse al equipo y dar soporte en la gestión regulatoria de productos, asegurando el cumplimiento de la normativa vigente a nivel nacional e internacional.u003c/divu003eu003cdivu003eLa persona seleccionada participará en actividades clave de registro y mantenimiento regulatorio, colaborando con equipos multidisciplinares.u003cbru003eu003c/divu003eu003cdivu003eu003cstrongu003eFunciones principalesu003c/strongu003eu003c/divu003eu003culu003eu003cliu003ePreparación, revisión y presentación de dossiers regulatoriosu003c/liu003eu003cliu003eGestión de registros de productos ante autoridades competentesu003c/liu003eu003cliu003eCoordinación de variaciones, renovaciones y lifecycle managementu003c/liu003eu003cliu003eGarantizar el cumplimiento normativo aplicableu003c/liu003eu003cliu003eRevisión de documentación técnica, etiquetado y claimsu003c/liu003eu003cliu003eInteracción con autoridades regulatorias cuando sea necesariou003c/liu003eu003cliu003eColaboración con departamentos internos (calidad, supply, laboratorio, etc.)u003c/liu003eu003c/ulu003eu003cdivu003eu003cstrongu003eRequisitosu003c/strongu003eu003c/divu003eu003culu003eu003cliu003eFormación en Farmacia, Química, Biología o similaru003c/liu003eu003cliu003eExperiencia previa en Regulatory Affairs (ideal 2 años)u003c/liu003eu003cliu003eConocimiento de normativa aplicable (EU/MDR/EMA/AEMPS según aplique)u003c/liu003eu003cliu003eExperiencia en registros y mantenimiento regulatoriou003c/liu003eu003cliu003eNivel alto de inglés (mínimo B2-C1)u003c/liu003eu003cliu003ePerfil organizado, analítico y con atención al detalleu003cbru003eu003cstrongu003e Valorableu003c/strongu003eu003c/liu003eu003cliu003eExperiencia en entorno pharma, bajo normativa GMPu003c/liu003eu003cliu003eConocimiento de eCTD u otros formatos regulatoriosu003c/liu003eu003cliu003eExperiencia en mercados internacionalesu003c/liu003eu003c/ulu003eu003cdivu003eu003cstrongu003eSe ofreceu003c/strongu003eu003c/divu003eu003culu003eu003cliu003eIncorporación a una compañía consolidadau003c/liu003eu003cliu003eEntorno dinámico y colaborativou003c/liu003eu003cliu003ePosibilidades de desarrollo profesionalu003c/liu003eu003cliu003eCondiciones salariales competitivas según experienciau003c/liu003eu003c/ulu003e #1126360 - Maria Claveria

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well‑being of people around the world. We are leaders in plasma‑derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.We believe that diversity adds value to our business, our teams, and our culture. We are committed to equal employment opportunity fostering an inclusive environment where diversity makes us be outstanding.In our Technical Area Department, we are looking for a QA Product Release Section Manager to manage product release activities for both manufactured and distributed products, ensuring compliance with Technical Direction guidelines and applicable regulatory requirements.What your responsibilities will be- Manage product release activities, evaluating technical and documental compliance according to Technical Direction guidelines.- Participate in the configuration of systems related to product release.- Coordinate communications with Notified Bodies, reference laboratories and related stakeholders.- Manage documentation storage, control and retrieval, including externally archived documentation.- Handle document management quality notifications, ensuring proper tracking and workflow.- Approve quality notifications after evaluating their impact on batch release and product status.- Monitor the status of materials affected by quality notifications.- Coordinate communications with Health Authorities (e.G., AEMPS) and Pharmacy Inspection regarding import/export activities.- Issue and manage authorizations and official letters required for import/export processes.- Ensure compliance with applicable regulations such as ISO 13485, IVDR and MDSAP.- Act as internal auditor and participate in supplier audits.- Participate in continuous improvement of the Quality Management System.Who you are- Bachelor's degree in Enigneering, Health Sciences or similar.- At least 3 years of experience in Quality Assurance or Regulatory Affairs.- Experience in regulated environments under ISO13485 and/or IVDR.- Experience in team management.- Experience in audits.- Cross‑functional and collaborative work with multiple departments.- Attention to detail and compliance.- Analytical ability and technical judgement in impact assessments.- English level is C1.What we offerIt is a brilliant opportunity for you, Grifols is fully aware that its employees are one of its major assets. We are committed to maintaining an atmosphere that encourages all our employees to develop their professional careers in an excellent working environment.We believe in diverse talent and want to remove any barriers that may hinder your participation. If you require any adjustments in our selection process, please do not hesitate to inform us when applying. We are here to help.Grifols is an equal opportunity employer.Flexible scheduleMonday‑Thursday 7‑10 to 16‑19h and Friday 8‑15h (with the same flexible start time).#J-18808-Ljbffr

Experteer Overview En este rol te incorporarás al equipo de Calidad para garantizar el cumplimiento GDP en distribución farmacéutica y apoyar la sucesión hacia Direccion Técnica. Contribuirás a sostener un sistema de calidad sólido, supervisando la trazabilidad, la gestión de incidencias y la coordinación de auditorías con clientes, proveedores y autoridades. Trabajarás de forma cercana con Operaciones y Regulatory Affairs en un entorno internacional y desafiante. Tu impacto se verá en la mejora continua del QMS, la gestión documental y la respuesta ágil ante hallazgos de cumplimiento. Buscamos un perfil autónomo con visión operativa que contribuya a la continuidad regulatoria y a la preparación para ocupar la Compensaciones / Beneficios • Mantener y mejorar el Sistema de Garantía de Calidad (QMS) en distribución GDP • Gestión documental de calidad: PNTs/SOPs, registros, evidencias, listas maestras • Seguimiento de KPIs de calidad y reporting • Participar en cualificación de proveedores y clientes • Supervisar instalaciones, equipos, calibraciones y mantenimiento • Planificación y ejecución de autoinspecciones GDP • Elaboración de informes y seguimiento de CAPAs • Participación en auditorías de clientes y coordinación de auditorías a terceros y proveedores • Gestión de incidencias y recall: desviaciones/no conformidades, reclamaciones, acciones CAPA • Liderar procesos de retirada de medicamentos y coordinación con AEMPS • Gestión de alertas y medidas regulatorias • Gestión operativa de serialización (SEVEM) y control de trazabilidad • Mantenimiento de documentación en sistemas internos (ShareME) • Funciones de Director Técnico Suplente: asegurar cumplimiento y continuidad, plan de sucesión Responsabilidades • Grado o Licenciatura en Farmacia • Experiencia en distribución farmacéutica bajo GDP • Gestión documental de calidad • Auditorías y autoinspecciones • Desviaciones y CAPA • Inglés alto (oral y escrito) Requisitos principales •

ppDesde la división bRAS RECRUITING /b especializada en selección directa, te acompañamos en la búsqueda de tu nuevo proyecto profesional. Actualmente, estamos reclutando un/a bTÉCNICO/A DE ASUNTOS REGULATORIOS HEALTHCARE /bpara empresa del sector químico en los alrededores de bSANT SADURNÍ D'ANOIA. /b /p ul liPreparar, mantener y actualizar la documentación regulatoria de productos sanitarios y farmacéuticos conforme a la normativa nacional e internacional (AEMPS, EMA, FDA, MDR, etc.). /li liGestionar los registros y renovaciones de productos sanitarios y medicamentos, asegurando el cumplimiento de requisitos legales y regulatorios en healthcare. /li liCoordinarse con los equipos de I+D, Calidad y Producción para garantizar la correcta integración de los requisitos regulatorios en todas las fases del ciclo de vida del producto. /li liParticipar en la elaboración y revisión de etiquetas, instrucciones de uso y material promocional siguiendo la legislación vigente en sanidad y healthcare. /li liDar soporte en auditorías y consultas regulatorias tanto internas como externas. /li liColaborar en la vigilancia post-comercialización y la gestión de incidencias o retiradas de producto según normativa de regulatory affairs. /li liMantener una actualización continuada sobre cambios normativos en salud, medical devices, medicamentos y productos afines. /li liGrado universitario en Farmacia, Ciencias de la Salud, Química, Biología, Biotecnología o similar. /li liExperiencia mínima de 3 años en funciones de Regulatory Affairs en sector sanitario, healthcare, medical devices o industria farmacéutica. /li liConocimiento actualizado de normativa europea y nacional sobre productos sanitarios y medicamentos. /li liCapacidad de análisis, organización y gestión de documentación regulatoria compleja. /li liNivel intermedio/alto de inglés (mínimo B2) para la gestión y redacción de documentación internacional. /li liValorable conocimiento en sistemas de gestión de calidad (ISO13485, GMP, etc.) y experiencia con autoridades regulatorias (AEMPS, EMA, FDA). /li /ul pNuestra búsqueda está enfocada a personas con atención al detalle, rigurosidad, capacidad analítica y habilidad para trabajar en equipo en entornos multidisciplinares. /p ul liContrato indefinido desde el primer momento. /li liSalario: entre 35.000€ - 45.000€ B/A. Existe flexibilidad dentro de la banda salarial en función del perfil aportado. /li liJornada laboral de lunes a viernes, con opciones de flexibilidad horaria y teletrabajo parcial. /li liPlan de formación continua en normativa regulatoria y desarrollo profesional en healthcare. /li liAmbiente profesional, innovador y con equipos multidisciplinares. /li liOportunidad de desarrollar tu carrera en proyectos de referencia en el ámbito sanitario y regulatory affairs en productos sanitarios y farmacéuticos. /li /ul /p #J-18808-Ljbffr

Quality Deputy Tech Director (GDP) - Pharma LogisticsApplylocations: Barcelona, Spaintime type: Full timeposted on: Posted Todayjob requisition id: R Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today!# Job DetailsAlcura is a Cencora-owned company specializing in clinical trial logistics management and healthcare services. They offer customized solutions for pharmaceutical companies, healthcare providers, and patients, including clinical trial management and patient support services.The GDP Deputy Director ensures the safe and compliant distribution of pharmaceutical products and medical devices in line with Good Distribution Practices (GDP) across the supply chain (EU and international).This role is responsible for maintaining a robust quality system, ensuring compliance with regulatory requirements (including AEMPS and EU GDP), and overseeing facilities, processes, documentation, and distribution activities. The position also acts as a key liaison with health authorities and supports audits, inspections, and continuous improvement initiatives.Key Responsibilities: Ensure compliance with GDP regulations across all operations Maintain and improve quality assurance systems and SOPs Manage audits (internal, external, and regulatory) and inspections Oversee product recalls, complaints, deviations, and CAPAs Ensure supplier qualification and regulatory compliance Monitor storage, transport conditions, and equipment qualification Manage controlled substances, export/import licenses, and regulatory processes Support training programs and continuous improvement initiativesQuality Management System: Collaborate closely with the QA team to investigate customer complaints and deviations related to sourced pharmaceutical products for clinical trials. Provide relevant information, documentation, and support to facilitate root cause analysis, define corrective and preventive actions (CAPAs), and ensure their effective implementation. Support actions aimed at preventing recurrence and driving continuous quality improvements. Participate in internal and external audits, ensuring readiness and compliance with applicable standards..Requirements: Degree in Pharmacy Proven experience in GDP / Quality Management Strong knowledge of pharmaceutical regulations Advanced EnglishNice to have: Experience in clinical trials Knowledge of controlled substances and GMO regulations* Familiarity with Quality Management Systems and risk assessmentbr#J-18808-Ljbffr

ppOur team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today! /p h3Job Details /h3 pAlcura is a Cencora‑owned company specializing in clinical trial logistics management and healthcare services. They offer customized solutions for pharmaceutical companies, healthcare providers, and patients, including clinical trial management and patient support services. /p pThe GDP Deputy Director ensures the safe and compliant distribution of pharmaceutical products and medical devices in line with Good Distribution Practices (GDP) across the supply chain (EU and international). This role is responsible for maintaining a robust quality system, ensuring compliance with regulatory requirements (including AEMPS and EU GDP), and overseeing facilities, processes, documentation, and distribution activities. The position also acts as a key liaison with health authorities and supports audits, inspections, and continuous improvement initiatives. /p h3Key Responsibilities /h3 ul liEnsure compliance with GDP regulations across all operations /li liMaintain and improve quality assurance systems and SOPs /li liManage audits (internal, external, and regulatory) and inspections /li liOversee product recalls, complaints, deviations, and CAPAs /li liEnsure supplier qualification and regulatory compliance /li liMonitor storage, transport conditions, and equipment qualification /li liManage controlled substances, export/import licenses, and regulatory processes /li liSupport training programs and continuous improvement initiatives /li /ul h3Quality Management System /h3 ul liCollaborate closely with the QA team to investigate customer complaints and deviations related to sourced pharmaceutical products for clinical trials. /li liProvide relevant information, documentation, and support to facilitate root cause analysis, define corrective and preventive actions (CAPAs), and ensure their effective implementation. /li liSupport actions aimed at preventing recurrence and driving continuous quality improvements. /li liParticipate in internal and external audits, ensuring readiness and compliance with applicable standards. /li /ul h3Requirements /h3 ul liDegree in Pharmacy /li liProven experience in GDP / Quality Management /li liStrong knowledge of pharmaceutical regulations /li liAdvanced Spanish and English /li /ul h3Nice To Have /h3 ul liExperience in clinical trials /li liKnowledge of controlled substances and GMO regulations /li liFamiliarity with Quality Management Systems and risk assessment /li liStrong organizational and multitasking skills /li liProactive and professional approach /li liLong‑term commitment to the organization /li liMotivated to grow and develop within the role /li /ul h3What Cencora offers /h3 pBenefit offerings outside the US may vary by country and will be aligned to local market practice. The eligibility and effective date may differ for some benefits and for team members covered under collective bargaining agreements. /p pFull time /p h3Affiliated Companies /h3 pAffiliated Companies: Alcura Health España S.A. /p h3Equal Employment Opportunity /h3 pCencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law. The company’s continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory. Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call or email We will make accommodation determinations on a request‑by‑request basis. Messages and emails regarding anything other than accommodation requests will not be returned. /p /p #J-18808-Ljbffr

pp¿Quieres impulsar tu carrera en Regulatory Affairs con foco en LATAM? En este rol te encargarás de gestionar expedientes regulatorios, preparar documentación técnica y coordinar estrategias de registro en diferentes países, en un entorno dinámico y de alcance internacional. /p h3¿Qué harás? /h3 ul liRealizarás y gestionarás la documentación técnica de los expedientes de registro, propios o de licencia, tanto para nuevos registros como para su mantenimiento (variaciones y renovaciones) en países de Centroamérica y LATAM. /li liPrepararás y gestionarás la documentación técnica de los expedientes de productos OTC en LATAM. /li liPlanificarás y crearás la estrategia regulatoria tanto para nuevos registros como para los cambios solicitados (variaciones de registro). /li liLlevarás a cabo tareas como realizar las notificaciones de exportación ante la AEMPS. /li liSolicitarás CPPs. /li /ul h3¿A quién buscamos? /h3 ul liTienes el Grado en Farmacia o afín. /li liTu experiencia es de al menos tres años como Técnico/a de Registros en la industria farmacéutica y has trabajado como Técnico/a Responsable. /li liTu nivel de inglés es B2 o superior. /li liSe valorará favorablemente si dispones de experiencia trabajando con LATAM. /li /ul h3¿Qué ofrecemos? /h3 ul liJornada laboral completa de lunes a jueves y viernes intensivo. /li liSalario competitivo. /li liFlexibilidad horaria de entrada y salida. /li liModalidad de trabajo híbrida. /li liBeneficios sociales. /li /ul /p #J-18808-Ljbffr