Sentinel Diagnostics, leader in the Development and Production of Diagnostic Kits for Clinical Chemistry, Immunology, Molecular Biology, Chromatography and Rapid Tests, in order to expand the RA Team, is looking for a:Esperienza, qualifiche e soft skill: possiede tutti i requisiti per avere successo in questa possibilità?
Lo scopra qui sotto.Senior Regulatory Affairs Specialist FDA & International RegistrationsKey Responsibilities:Define and implement regulatory strategies to support business decisions related to US product registrationsPrepare and manage FDA premarket submissions, like 510(k) or CLIA categorizationCoordinate interactions with regulatory consultants and FDA representativesProvide regulatory guidance to cross-functional teams throughout the product lifecycle, ensuring compliance with applicable FDA regulations and guidance documentsWork closely with R&D;, Clinical Affairs, Quality Assurance, Operations,



and Marketing teamsSupport generation and review of analytical and clinical performance study reportsRequirements:Scientific DegreeDeep understanding of FDA regulatory requirements for IVD devices, including device registration and listing, labeling requirements, Quality System Regulations (QSR), Medical Device Reporting (MDR), and FDA submission processesDemonstrated experience in FDA 510K submissions of In Vitro Diagnostic Devices, including management of US clinical samplesProven successful interactions with the US Agency, CROs, distributors and regulatory consultants.
xysqume Availability for frequent international travels, including United StatesFluent in English, Italian language is a plusStrong interpersonal skills and teamworking abilityInitiative and reliabilityWhat We offerPermanent contract, full-timeGross annual salary starting from € ****** plus annual bonusCompany welfareDaily meal vouchersWork Location : Hybrid (on site in Milan and remote)#J-*****-Ljbffr

📌 Senior Regulatory Affairs Specialist Fda (Bardi)
🏢 Sentinel Diagnostics Group
📍 Bardi