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

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📌 QA Product Release Section Manager (Madrid)
🏢 Jobtailor
📍 Madrid