Requirements: English
Company: Mectron Medical
Region: Carasco , Liguria
MECTRON SPA , A DESIGNER AND MANUFACTURER OF DENTALAND MEDICAL DEVICES IS LOOKING FOR Regulatory Affairs SpecialistThe Regulatory Affairs Specialist assists the SeniorRegulatoryAffairs Managerin the registration of medical devices in EXTRA-CEEcountries following a plan that is constantly updated in accordancewith company strategy. Essential Duties and Responsibilities -prepares, updatesand reviews the documents for use in in regulatorydossiers in accordance with EU MOR 745/2017 and internationalrequirements. - Prepares and manages technicaldocumentations neededfor submission and registrations; - Interacts with projectdevelopments teams in order to collect the information needed forsubmissions/ registrations and advise them on matters that arerelated to regulatory processes and compliance - Registers,monitors, and maintains registrations for the company''s medicaldevices with EXTRA - CEE countries'' competent authorities asappropriate; - Assist in theCompliance to the Medical DeviceRegulations (MDR) in the EU, Canadian Medical Device Directive,FDA, TGA, ANVISA, Japan Authority and other regulatory agencies; -Is also proficient in applicable standards and regulationsincluding: ISO 13485, ISO 9001, ISO 14971, ISO 10993, ISO 11607 andMEDDEV guidelines; - Prepares and updates the Quality andRegulatory Agreements necessary for registration purposes,distribution contracts and technical assistance for the EXTRA - CEEcountries concerned; - Follows and promotes corporate qualityprocedures and standards in order to achieveand maintain adequateresults; - Actively participate in audit activities. WorkExperience - Required Qualifications At least 3 years'' experiencewith Regulatory Affairs in the medical device industry preferred; ISO 13485 Fluent in English; Internal Auditor Qualificationspreferred. Educational Requirements Bachelor''s Degree in scientificdiscipline; Higher-level education degree preferred.