Laatu- ja regulaatioasiantuntija

Esko Systems is a customer-owned in-house company through which owner organizations can procure and participate in developing modern information system solutions that support patient- and customer-facing work. Esko Systems is building an integrated patient information system (APTJ) for the needs of welfare regions. We offer meaningful work in close collaboration with owner-customers in the Finnish social and health ICT landscape. Esko has been awarded the Key Flag Symbol by the Finnish Salute Integrity. We are developing regionally strong patient information system solutions where information follows the patient to ensure patient safety and mobility of information from primary care to specialized care. Our products have a long history of thirty years, and we have deep experience in what makes a good user experience. You can learn more about us here: https://eskosystems.fi/yritys/. We are seeking a customer-oriented, growing, and strongly developing Esko team member for the Quality and Regulatory area. The role focuses on ensuring that our health IT software meets the quality, safety, and regulatory requirements for medical devices, with emphasis on MDR, technical documentation, ISO 13485 quality management system, and practical application of new regulations such as the EU AI Act. This is not a management role but a strong expert position where you can influence quality management development and interact with internal development processes as well as audit authorities and customers. In the role you will participate in ensuring regulatory compliance of medical software, creating and maintaining technical documentation, supporting risk management, preparation for audits, and guiding the organization on quality and regulatory matters. You will interpret complex regulations into practical requirements and advance things in a systematic way together with other experts.