Junior QA/RA Specialist — Build IVD Quality & CE

Barrington James; Madrid; Presencial; EUR 40.000 - 55.000; Jornada completa

Descripción de la vacante

An innovative medical device company in Madrid is looking for a Junior QA / RA Specialist to support the development of their Quality & Regulatory function. In this role, you will help build and implement ISO 13485-compliant processes while assisting in the regulatory dossier preparation for CE marking of a Class C diagnostic device. The ideal candidate will have 3-5 years of experience in QA/RA, strong communication skills, and a keen attention to detail. This position offers an exciting ground-floor opportunity with mentorship and career progression.

Servicios

Ground-floor opportunity

Direct mentorship

Long-term career progression

Formación

• 3-5 years experience in QA/RA within IVD, medical devices, biotech, or diagnostics.
• Knowledge of EU IVDR, ISO 13485, design controls, and technical documentation.
• Experience supporting Notified Body interactions.

Responsabilidades

• Support implementation and maintenance of ISO 13485-compliant QMS.
• Assist in preparation and submission of the Regulatory Dossier for CE Marking.
• Manage technical documentation and ensure compliance with EU IVDR.

Conocimientos

QA / RA experience

Attention to detail

Communication skills

Project management

Herramientas

ISO 13485

EU IVDR

Descripción del empleo

An innovative medical device company in Madrid is looking for a Junior QA / RA Specialist to support the development of their Quality & Regulatory function. In this role, you will help build and implement ISO 13485-compliant processes while assisting in the regulatory dossier preparation for CE marking of a Class C diagnostic device. The ideal candidate will have 3-5 years of experience in QA/RA, strong communication skills, and a keen attention to detail. This position offers an exciting ground-floor opportunity with mentorship and career progression.