Ground-floor QA/RA Specialist - IVD Start-up (Barcelona)

Barrington James; Madrid; Presencial; EUR 50.000 - 70.000; Jornada completa

Descripción de la vacante

An innovative IVD start-up in Barcelona is seeking a Junior QA / RA Specialist to build and implement their Quality & Regulatory function. The role involves supporting the CE marking of a Class C diagnostic device, managing regulatory submissions, and coordinating with various stakeholders. Ideal candidates should have 3-5 years of relevant experience and strong attention to detail. This position offers unique growth opportunities and direct mentorship from senior leadership.

Servicios

Ground-floor opportunity to build a function

Direct mentorship from leadership

Involvement in CE marking process

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.
• Coordinate with Notified Body and participate in regulatory interactions.
• Manage technical documentation including performance evaluation planning.

Conocimientos

Attention to detail

Cross-functional collaboration

Communication skills

Project management

Descripción del empleo

An innovative IVD start-up in Barcelona is seeking a Junior QA / RA Specialist to build and implement their Quality & Regulatory function. The role involves supporting the CE marking of a Class C diagnostic device, managing regulatory submissions, and coordinating with various stakeholders. Ideal candidates should have 3-5 years of relevant experience and strong attention to detail. This position offers unique growth opportunities and direct mentorship from senior leadership.