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