QA/RA Specialist
hace 5 días
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: +44 (0) #QualityAssurance #RegulatoryAffairs #IVD #MedicalDevices #Barcelona #Hiring
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Quality and Regulatory associate Junior
hace 2 semanas
Catalonia, España Mediktor A tiempo completoMediktor is looking for a QA/RA specialist! If you are passionate about applying the regulation to cutting edge technology and you would like to discover the Software Medical Device regulation, we are looking for you! The Team: As a member of the Quality Department, you will collaborate closely with all teams and departments at Mediktor, supporting them in...
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Quality and Regulatory associate Junior
hace 2 semanas
Catalonia, España Mediktor A tiempo completoMediktor is looking for a QA/RA specialist!If you are passionate about applying the regulation to cutting edge technology and you would like to discover the Software Medical Device regulation, we are looking for you!The Team:As a member of the Quality Department, you will collaborate closely with all teams and departments at Mediktor, supporting them in...
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QC Specialist
hace 2 semanas
Catalonia, España QP Group A tiempo completoA leading European CDMO is seeking a QC Specialist – Stability to join their growing Quality Control team in Girona. This role is ideal for an analytical scientist with strong experience in biologics and a passion for high-quality, GMP-compliant work.Key ResponsibilitiesLead and execute stability studies for biologic products.Perform and troubleshoot...
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QC Specialist
hace 2 semanas
Catalonia, España QP Group A tiempo completoA leading European CDMO is seeking a QC Specialist – Stability to join their growing Quality Control team in Girona. This role is ideal for an analytical scientist with strong experience in biologics and a passion for high-quality, GMP-compliant work. Key Responsibilities Lead and execute stability studies for biologic products. Perform and troubleshoot...
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Qc specialist
hace 2 semanas
Catalonia, España QP Group A tiempo completoA leading European CDMO is seeking a QC Specialist – Stability to join their growing Quality Control team in Girona. This role is ideal for an analytical scientist with strong experience in biologics and a passion for high-quality, GMP-compliant work. Key Responsibilities Lead and execute stability studies for biologic products. Perform and troubleshoot...
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Quality and Regulatory associate Junior
hace 2 semanas
Catalonia, España Mediktor A tiempo completoMediktor is looking for a QA/RA specialist!If you are passionate about applying the regulation to cutting edge technology and you would like to discover the Software Medical Device regulation, we are looking for you!The Team:As a member of the Quality Department, you will collaborate closely with all teams and departments at Mediktor, supporting them in...
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Analytics Implementation Specialist
hace 7 días
Catalonia, España Dow Jones A tiempo completoAbout Our Organization:Dow Jones is a global provider of news and business information, delivering content to consumers and organizations around the world across multiple formats, including print, digital, mobile and live events. Dow Jones has produced unrivaled quality content for more than 130 years and today has one of the world's largest news-gathering...
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Analytics Implementation Specialist
hace 4 semanas
Catalonia, España Dow Jones A tiempo completoAbout Our Organization: Dow Jones is a global provider of news and business information, delivering content to consumers and organizations around the world across multiple formats, including print, digital, mobile and live events. Dow Jones has produced unrivaled quality content for more than 130 years and today has one of the world's largest news-gathering...
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Analytics Implementation Specialist
hace 7 días
Catalonia, España Dow Jones A tiempo completoAbout Our Organization: Dow Jones is a global provider of news and business information, delivering content to consumers and organizations around the world across multiple formats, including print, digital, mobile and live events. Dow Jones has produced unrivaled quality content for more than 130 years and today has one of the world's largest news-gathering...
