Descripción de la oferta
We are representing a high-growth Barcelona-based Med Tech innovator specializing in the next generation of Molecular Diagnostics (IVD). Our client has successfully transitioned from R& D excellence to commercial manufacturing and is now looking for a strategic technical leader to act as the legal and operational guardian of their product launches.Compruebe que cumple con los requisitos de habilidades para este puesto, así como con la experiencia asociada, y luego envíe su CV a continuación.Key Responsibilities:Fulfil the critical responsibilities of the PRRC under IVDR Article 15 and act as the Responsable Técnico in accordance with Spanish national legislation (RD 192/2023 and RD 942/2025).Hold ultimate responsibility for the quality control release of all IVD products manufactured at the Barcelona facility.Review and approve batch records, certificates of analysis (Co A), and associated quality documentation in compliance with EU IVDR (2017/746) and AEMPS requirements.Provide direct supervision of QC testing activities and ensure laboratory operations meet the highest standards (ISO 13485).Manage non-conformances, deviations, and OOS (out-of-specification) investigations linked to release activities.Partner with Manufacturing, Supply Chain, and Regulatory Affairs to ensure on-time release without compromising quality or safety.QMS Excellence: Design, maintain, and improve release-related SOPs and work instructions.Support internal and external audits, including inspections by Notified Bodies and health authorities.Qualifications & Experience:Bachelor's degree in Life Sciences is mandatory to fulfill legal status; an advanced degree (MSc or Ph D) is strongly preferred.8+ years within the IVD or diagnostics sector.Strong background in molecular diagnostics, PCR-based assays, or nucleic acid technologies is highly valued.Deep mastery of ISO 13485, EU IVDR (2017/746), and AEMPS regulations (including RD 942/2025).Proven experience with batch release in regulated, clean manufacturing environments using Quality by Design (Qb D) principles. xcskxlj Native or professional fluency in both English and Spanish.
