Laiteturvallisuusasiantuntija - Lääkealan turvallisuus- ja kehittämiskeskus Fimea

Fimea supervises the compliance of medical devices and industry operators in Finland. The supervision covers medical devices on the market and their professional use and maintenance. Additionally, Fimea monitors marketing activities of medical devices, handles incident reports, and issues certificates of market access, research, and exceptional permits. Fimea is the designated competent authority for medical devices in Finland within the European Union. Its responsibilities also include international cooperation related to medical devices, collaboration with EU surveillance authorities, and representing Finland in sector working groups established by the EU Commission. The Medical Device Safety Specialist positions are located within the Medical Devices unit, under the Safety and Availability section, which focuses on incident registration and handling, supervision of professional use, and tasks related to device availability information. The duties of the available positions include: Handling reports related to medical devices Guiding and advising Fimea’s clients Participating in coordination and handling of European authority inquiries on medical devices Participating in inspections of professional users of medical devices, depending on experience and expertise Contributing to the development of information systems.