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Recruitment Consultant | Quality Assurance & Regulatory Affairs | UK & Europe
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
* 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:
Seniority level: Associate
Employment type: Full-time
Job function: Quality Assurance
Industries: Medical Equipment Manufacturing and Biotechnology Research
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