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 *****, 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 ISO***** 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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