Qa Product Release Section Manager
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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.
- 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.
- Bachelor's Degree in Engineering
- Bachelor's Degree in Health Sciences
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