Position Summary: The Quality & Regulatory Manager is responsible for managing the QA/QC & RA of products and processes to ensure that they meet industry standards in accordance with ISO 13485 standard and MDR (2017/745). The responsibilities range from Quality Assurance (i.e, create SOP, training plan, polivalent matrix, measurement and calibration, non conformance management, internal and external audits...) Quality control (incoming inspection, verification of documents...) to Regulatory Affairs of products (registration of product on health authority, health & Safety...). […]
Manage the complaints...