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