16 ott - Milano
Sentinel Diagnostics Group
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:
Senior Regulatory Affairs Specialist FDA & International Registrations
Key Responsibilities
Define and implement regulatory strategies to support business decisions related to US product registrations
Prepare and manage FDA premarket submissions, like 510(k) or CLIA categorization
Coordinate interactions with regulatory consultants and FDA representatives
Provide regulatory guidance to cross-functional teams throughout the product lifecycle, ensuring compliance with applicable FDA regulations and guidance documents
Work closely with R&D;, Clinical Affairs, Quality Assurance, Operations, and Marketing teams
Support generation and review of analytical and clinical performance study reports
Requirements
Scientific Degree
Deep 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 processes
Demonstrated experience in FDA 510K submissions of In Vitro Diagnostic Devices, including management of US clinical samples
Proven successful interactions with the US Agency, CROs, distributors and regulatory consultants.
Availability for frequent international travels, including United States
Fluent in English, Italian language is a plus
Strong interpersonal skills and teamworking ability
Initiative and reliability
What We offer
Permanent contract, full-time
Gross annual salary starting from € 50.000 plus annual premio
Company welfare
Daily meal vouchers
Work Location : Hybrid (on site in Milan and remote)
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