Technical Responsible & Release Lead (Ivd)en Barcelona.

We are representing a high-growth Barcelona-based MedTech innovator specializing in the next generation of Molecular Diagnostics (IVD).

our client

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.

your functions

- 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 (CoA), 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.

position requisites

• Formación

  : Licenciado

• Idiomas

  : Inglés: C1

• Conocimientos

  : diagnostico in vitro (ivd)

• Experiencia

  : 8 años

- Bachelor¿s degree in Life Sciences is mandatory to fulfill legal status; an advanced degree (MSc or PhD) 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 (QbD) principles.
- Native or professional fluency in both English and Spanish.

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