We are representing a high-growth Barcelona-based MedTech 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.
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 (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.
Qualifications & Experience:
- Bachelor’s degree in Life Sciences is mandatory to fulfill legal status;
an advanced degree (MScor 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.