Quality Regulatory Manager

Elemed; España; Presencial; EUR 30.000 - 50.000; Jornada completa

Descripción de la vacante

Una empresa internacional de tecnología quirúrgica busca un RAQA Lead para gestionar el sistema de calidad en su oficina de Barcelona. Este rol clave involucra la colaboración con líderes comerciales y la gestión de la vigilancia post-comercialización. Se requiere experiencia de al menos 5 años en aseguramiento de calidad o asuntos regulatorios en dispositivos médicos, así como fluidez en español e inglés, y se valora el conocimiento de portugués y catalán. Esta posición ofrece oportunidades en un entorno diverso y en crecimiento.

Formación

• Mínimo 5 años en un rol de aseguramiento de calidad o asuntos regulatorios en la industria de dispositivos médicos.
• Experiencia liderando operaciones o proyectos RAQA para dispositivos médicos.
• Fluidez en español e inglés, conocimiento de portugués y catalán es un plus.

Responsabilidades

• Mantener el sistema de gestión de calidad para la organización española.
• Colaborar con el líder comercial regional para asegurar la disponibilidad de dispositivos.
• Gestionar operaciones de vigilancia post-comercialización (PMS) y PMCFs.
• Liderar la recolección de datos clínicos y procesos de retroalimentación de cirujanos.
• Preparar y liderar las reuniones de revisión de gestión de calidad.
• Entrenar y asesorar en funciones RAQA en otras oficinas EMEA.
• Identificar requisitos regulatorios locales y liderar evaluaciones de impacto.
• Ejecutar registros regulatorios locales donde sea necesario.
• Apoyar auditorías internas y externas.
• Actividades regulatorias EMEA referentes a requisitos de importador y representante autorizado.

Conocimientos

Gestión de calidad

Relaciones regulatorias

Comunicación en inglés

Interacción con cirujanos

Descripción del empleo

Title : RAQA Lead - Spain and Portugal

Location : Barcelona, Spain

Contact :

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The company

Are you someone who has Iberia-wide regulatory experiences and are looking for the next step in your medical devices career at the EMEA level? Are you someone who likes to think creatively and prioritizes medical devices that are always accessible to patients and surgeons on the market? Do you like working with both active and non-active devices?

Here is a rare and great opportunity to join an international leader in surgical technology and be part of this company’s regional growth strategy in Spain and Portugal and be visible at the EMEA-level. As the Regional QARA Lead for the IBERIAN region, you will be based at their Spain branch office in Barcelona, where they have centralised sales, marketing, customer success teams all in one place.

This is a company-critical role and your past experiences in registrations can help the company to reach their business goals for the EMEA region.

This exciting position will give you the opportunity to work in a diverse international environment.

You will be responsible for the quality system of the sales office in Barcelona as well as supporting the registrations for Spain. Furthermore, you are part of the EMEA Quality Assurance and Regulatory affairs team, for this region you will be responsible for collecting clinical data from surgeons to assist the HQ in the US with clinical surveillance.

In this role you will report directly to the Sr Director Quality Assurance and Regulatory Affairs International

Responsibilities

• Maintain the Quality Management System for their Spanish Organization
• Work with the Regional Commercial leader to ensure the medical device portfolio remain commercially available and compliant
• Manage Post-Market Surveillance (PMS) operations and PMCFs
• Leading clinical data collection and surgeon feedback processes for submission and PMCFs
• Prepare and lead the quality management review meetings
• Training and coaching people in RAQA functions in other EMEA offices on the procedures and processes
• Identify local regulatory requirements and lead impact assessment which is driving quality management system changes
• Execute Local regulatory registrations where necessary
• Supporting internal and external audits
• EMEA regulatory affairs activities concerning importer and authorized representative requirements

Qualifications

• At least 5 years in a quality assurance or regulatory affairs role in the medical device industry
• Led the RAQA operations or projects for medical devices
• Fluent written & spoken in Spanish and English (bonus if Portuguese and Catalan as well)
• Office-presence 3 days per week in Barcelona city-centre

If you are interested in this exciting role, please send your application directly to

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Please note : Only candidates meeting the requirements set out in the role profile above, will be considered in the application process.

Due to the high volume of applications we receive, our team might not be able to contact each applicant individually regarding the status of their application. If you do not hear from us after 10 days, please consider your application unsuccessful.