Regulatory Affairs Specialist

Social network you want to login/join with: MECTRON SPA, a designer and manufacturer of dental and medical devices, is looking for a Regulatory Affairs Specialist . The Regulatory Affairs Specialist assists the Senior Regulatory Affairs Manager in the registration of medical devices in EXTRA-CEE countries, following a plan that is constantly updated in accordance with company strategy. Essential Duties and Responsibilities Prepare, update, and review documents for regulatory dossiers in accordance with EU MDR 745/2017 and international requirements. Prepare and manage technical documentation needed for submissions and registrations. Interact with project development teams to collect information needed for submissions/registrations and advise on regulatory compliance matters. Register, monitor, and maintain registrations for the company's medical devices with EXTRA-CEE countries' authorities as appropriate. Assist in compliance with Medical Device Regulations (MDR) in the EU, Canadian Medical Device Regulations, FDA, TGA, ANVISA, Japan authorities, and other agencies. Proficient in standards and regulations including ISO 13485, ISO 9001, ISO 14971, ISO 10993, ISO 11607, and MEDDEV guidelines. Prepare and update Quality and Regulatory Agreements for registration, distribution contracts, and technical assistance in the EXTRA-CEE countries. Follow and promote corporate quality procedures and standards to achieve and maintain compliance. Participate actively in audit activities. Work Experience - Required Qualifications - At least 3 years of experience in Regulatory Affairs within the medical device industry preferred. - Fluent in English. Educational Requirements Bachelor's Degree in a scientific discipline. J-18808-Ljbffr

Location: provincia-di-genova, IT

Posted Date: 6/16/2025