Requirements: English
Company: JR Italy
Region: Uri , Sardinia
The Regulatory Affairs Specialist plays a crucial role in the registration of medical devices in EXTRA-CEE countries. The ideal candidate will assist the Senior Regulatory Affairs Manager in developing and implementing a plan to ensure compliance with EU MDR 745/2017 and international regulations.Key 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.Maintain proficiency in applicable standards and regulations, including ISO 13485, ISO 9001, ISO 14971, ISO 10993, ISO 11607, and MEDDEV guidelines.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