Requirements: English
Company: JR Italy
Region: Uri , Sardinia
The Regulatory Affairs Specialist is responsible for ensuring the registration of medical devices in EXTRA-CEE countries. This includes preparing, updating, and reviewing documents for regulatory dossiers, managing technical documentation, registering and maintaining registrations, and ensuring compliance with relevant regulations.Main ResponsibilitiesPrepare, update, and review documents for regulatory dossiers in accordance with EU MDR 745/2017 and international requirements.Manage technical documentation needed for submissions and registrations, interacting with project development teams to collect necessary information.Register, monitor, and maintain registrations for the company''s medical devices with EXTRA-CEE countries'' competent authorities as appropriate.Ensure compliance with Medical Device Regulations (MDR) in the EU, Canadian Medical Device Directive, FDA, TGA, ANVISA, Japan Authority, and other regulatory agencies.Prepare and update quality and regulatory agreements necessary for registration purposes, distribution contracts, and technical assistance for EXTRA-CEE countries.Participate in audit activities and promote corporate quality procedures and standards to achieve adequate results.#J-18808-Ljbffr