Requirements: English
Company: JR Italy
Region: Uri , Sardinia
About the Role We are seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory affairs department, you will play a vital role in ensuring the registration of medical devices in EXTRA-CEE countries. Main Duties and Responsibilities Preparation and Review of Documents: Prepare, update, and review documents for use in regulatory dossiers in accordance with EU MDR 745/2017 and international requirements. Technical Documentation Management: Manage technical documentation needed for submissions and registrations, interacting with project development teams to collect necessary information. Registration and Maintenance: Register, monitor, and maintain registrations for the company''s medical devices with EXTRA-CEE countries'' competent authorities as appropriate. Compliance and Regulation: Ensure compliance with Medical Device Regulations (MDR) in the EU, Canadian Medical Device Directive, FDA, TGA, ANVISA, Japan Authority, and other regulatory agencies. Quality and Regulatory Agreements: Prepare and update quality and regulatory agreements necessary for registration purposes, distribution contracts, and technical assistance for EXTRA-CEE countries. Audit Participation: Participate in audit activities and promote corporate quality procedures and standards to achieve adequate results. #J-18808-Ljbffr