QA​/RA Specialist

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:

✉ lcat
☎

#Quality Assurance #Regulatory Affairs #IVD #Medical Devices #Barcelona #Hiring