QA Specialist (medical devices)

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

QA / RA Specialist | IVD Start-up | Barcelona

An innovative IVD start-up is seeking a Junior QA / RA Specialist to help build and implement their Quality & Regulatory function as they prepare for CE marking of a Class C diagnostic device for kidney disease detection.

Key Focus Areas

• Support implementation and maintenance of ISO 13485-compliant QMS including SOPs, work instructions, and quality documentation
• Assist in preparation and submission of the Regulatory Dossier for CE Marking (Class C IVD)
• Coordinate with Notified Body and participate in regulatory interactions
• Manage technical documentation including performance evaluation planning, risk management files, and design control evidence
• Ensure compliance with EU IVDR and track regulatory timelines and deliverables
• Collaborate with R&D, clinical partners, and external manufacturers to support industrialization

Requirements

• ~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
• ~ Strong attention to detail with ability to work cross-functionally in a fast-paced environment
• ~ Good communication and project management skills

Benefits

• Ground-floor opportunity to build a regulatory & quality function from scratch
• Direct mentorship and exposure to senior leadership (CEO / CTO)
• Hands-on involvement in CE marking process and industrialization
• Long-term career progression as the company scales

If you're interested in learning more, feel free to reach out or apply below :

✉ [e-mail]

☎ [phone]

#QualityAssurance #RegulatoryAffairs #IVD #MedicalDevices #Barcelona #Hiring