Regulatory Affairs Specialist

Sentinel Diagnostics, leader in the Development and Production of Diagnostic Kits for Clinical Chemistry, Immunology, Molecular Biology, Chromatography and Rapid Test, in order to expand the Regulatory Affairs Team, is looking for a:REGULATORY AFFAIRS SPECIALISTResponsibilities:Definition of regulatory strategies for global market access of In Vitro Diagnostic medical devices, in accordance with the company prioritiesPreparation and submission of the mandatory technical and legal documentation files for worldwide product registration approvals, including the European and US marketsCollaboration with distributors Regulatory Affairs functionsMonitoring of the new international applicable requirements in order to support the company businessContinuous maintenance of the products conformity to applicable laws, regulations, guidelines and international standardsParticipation in corporate projects in order to provide regulatory guidance to cross-functional teamsRequirements:Scientific DegreeAt least 3/4 years of experience in similar role within the Medical Device/IVD sector, possibly in an international contextExcellent knowledge of national and international regulatory regulations (ISO *****, ISO ****, MDSAP, IVDR ********, US FDA 21 CFR )Good knowledge of the regulatory management of In Vitro Diagnostic Medical Devices (IVD)Any additional knowledge of the regulatory management of In Vitro Diagnostic Medical Devices (MDCG Guidelines, Anvisa, Health Canada, 510K) will be a preferential requirementFluent in EnglishAbility to interact with the different teams in the organizationCapacity to meet deadlines and focus on prioritiesProactivity and autonomyMotivation and enthusiasmLocation:Milan (Lorenteggio)Si invita a prendere visione della nostra informativa sul trattamento dei dati personali all'indirizzo: