Responsibilities
* 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
* 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 (España)
🏢 Grifols
📍 España