Ivdr Regulatory Affairs Trainee

hace 4 días

Barcelona, España EUROPEAN TELEMEDICINE CLINIC S.L A tiempo completo

Promotes a culture of quality by educating others in quality management system fundamentals, programs, and tools.
- Monitors in collaboration with procurement team the compliance readiness of suppliers of commercial CE-IVD devices with IVDR.
- Contributes to the continuous improvement: indicators and dashboards, implementation, and monitoring of preventive and corrective actions during IVDR Implementation project.
- Provides support on the implementation of the risk management procedure in all laboratories.
- Supports Quality Management activities and training related to new procedures design and maintenance, contributing to the continuous improvement culture.
- Provides support, under PMO supervision, on the activities related to the implementation of the European In-Vitro Diagnostic Regulation (IVDR) in all laboratories.
- Regulatory Intelligence follow up.
- Performs other duties as assigned.

**Organization
- Reporting line: IVDR Regulatory Affairs Manager
- Location: Barcelona Full time position

**Education, Experience and Skills
- Bachelor’s degree or master’s degree in technical/process engineering/QA/ Medical Device discipline, with significant related professional experience within the laboratory environment.
- Ideally experience with medical device regulation and/or in-vitro diagnostic directive regulation.
- Demonstrated ability to affect change.
- Excellent interpersonal, organizational & communication skills with excellent atention to detail.
- Self-motivated and driven critical thinker able to work in high pace and rapidly changing environment.
- Responsive problem solver and action oriented.
- English fluent as a must (presenting, writing, reading).

  • Trainee Regulatory Affairs

    hace 1 semana

    Barcelona, España HARTMANN A tiempo completo

    En HARTMANN nos dedicamos a **ayudar**, **cuidar**, **proteger** y **crecer**. Apoyamos a los profesionales de la salud para que puedan concentrarse en lo que realmente importa: impactar positivamente en la vida de las personas. Creamos soluciones que marcan la diferencia, y con tu compromiso podrás desarrollarte profesionalmente cada día. En HARTMANN tu...

  • Regulatory Affairs Trainee

    hace 2 semanas

    Barcelona, España HARTMANN A tiempo completo

    Únete a nuestro equipo como **Regulatory Affairs Trainee** ESP-Mataró (Barcelona) Aprovecha la nueva oportunidad que te ofrece HARTMANN en el **Área de Regulatory Affairs**. **Responsabilidades** - En relación con las comunicaciones de puesta en el mercado a la AEMPS por cada producto sanitario que ponemos en el mercado: - Reunir la documentación...

  • Global Director of Regulatory Affairs

    hace 1 semana

    Barcelona, España Tempus A tiempo completo

    **Passionate about precision medicine and advancing the healthcare industry?** Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way. Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, providing...

  • Regulatory Trainee Iberia

    hace 4 días

    Barcelona, España UPL ltd A tiempo completo

    **Regulatory Trainee Iberia**: - Job Id: 6473- City: BARCELONA, Catalunya, Spain- Department: Regulatory Affairs- Function: Regulatory, Research and Development- Employee Type: Temporary Full Time- Seniority Level: Internship- Description: **Young Talent Program - Regulatory Trainee (Internship)** ¿Te gustaría unirte a una empresa agroquímica...

  • Regulatory Affairs Trainee

    hace 2 semanas

    Barcelona, España Viatris A tiempo completo

    1750 Viatris Pharmaceuticals S.L. 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...

  • Regulatory Affairs

    hace 6 días

    Barcelona, España ABCDx SA A tiempo completo

    Overview Join a mission-driven team focused on changing the future of brain injury diagnostics. ABCDx is building AI-powered, life-saving diagnostic technologies such as ThromboCheck (FDA-bound point-of-care D-dimer) and LVOCheck (prehospital diagnostic support for LVO stroke). We’re seeking a hands-on RA/QA leader to drive regulation, innovation, and...

  • Regulatory Trainee Iberia

    hace 4 días

    Barcelona, España UPL NA Inc. A tiempo completo

    Job Id: 6473- City: BARCELONA, Catalunya, Spain- Department: Regulatory Affairs- Function: Regulatory, Research and Development- Employee Type: Temporary Full Time- Seniority Level: InternshipDescription: **Young Talent Program - Regulatory Trainee (Internship)** ¿Te gustaría unirte a una empresa agroquímica internacional? **UPL es una organización...

  • Regulatory Affairs Junior

    hace 6 días

    Barcelona, España Page Personnel España A tiempo completo

    Técnico/a para la preparación de la documentación regulatoria de los productos desarrollados por la empresa, complementos alimenticios, productos sanitarios clase IIa, productos sanitarios in vitro y cosméticos. Formación en Ciencias de la Salud|Prácticas en RA y/o Máster en Registros - Formación en Ciencias de la Salud: Farmacia, biología,...

  • Regulatory Affairs Specialist

    hace 2 semanas

    Barcelona, España ESTEVE A tiempo completo

    Job description: 1. FUNCTIONAL CONTENT Main Role The Regulatory Affairs Specialist will be responsible for managing the regulatory lifecycle of US FDA-approved products, ensuring ongoing compliance and supporting regulatory activities for the ongoing new product development projects. This role requires close collaboration with cross-functional teams...

  • Regulatory Affairs Manager

    hace 2 semanas

    Barcelona, España Jordan martorell s.l. A tiempo completo

    Job Title: European Regulatory Affairs Manager Location: Madrid, Spain - Hybrid Remuneration: Competitive salary and package Regulatory Affairs Manager opportunity working for an established pharmaceutical company that specialises in generic, OTC, and prescription medicines. The business is increasingly growing and is looking for a personable and...