Responsibilities Si desea conocer los requisitos para este puesto, siga leyendo para obtener toda la información relevante. * Manage product release activities, evaluating technical and documental compliance according to Technical Direction guidelines * Participate in the configuration of systems related to product release * Coordinate communications with Notified Bodies, reference laboratories and related stakeholders * Manage documentation storage, control and retrieval, including externally archived documentation * Handle document management quality notifications, ensuring proper tracking and workflow * Approve quality notifications after evaluating their impact on batch release and product status * Monitor the status of materials affected by quality notifications * Coordinate communications with Health Authorities (e.g., AEMPS)



regarding import/export activities * Issue and manage authorizations and official letters required for import/export processes * Ensure compliance with applicable regulations such as ISO 13485, IVDR and MDSAP * Act as internal auditor and participate in supplier audits * Participate in continuous improvement of the Quality Management System. Requirements * Bachelor's degree in Engineering, Health Sciences or similar * At least 3 years of experience in Quality Assurance or Regulatory Affairs * Experience in regulated environments under ISO13485 and/or IVDR * Experience in team management xqysrnh * Experience in audits * Excellent communication skills * Cross-functional and collaborative work with multiple departments * Attention to detail and compliance * Analytical ability and technical judgement in impact assessments * English level is C1. Certifications & Qualifications * Bachelor's Degree in Engineering * Bachelor's Degree in Health Sciences

📌 QA Product Release Section Manager (Parets)
🏢 Grifols
📍 Parets