QA Product Release Section Manager

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