Senior Regulatory Affairs Specialist FDA
Company: Sentinel Diagnostics
- Location: Milan, Italy
- Work mode: Hybrid
- Seniority: Senior
- Employment type: Full-time
- Posted: 12 days ago
- Offer language: English
Job description
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 bonus
- Company welfare
- Daily meal vouchers
Work Location: Hybrid (on site in Milan and remote)
La ricerca è estesa ad entrambi i sessi (L. 903/77 e 125/91).
Si invita a prendere visione della nostra informativa sul trattamento dei dati personali all'indirizzo: https://www.sentineldiagnostics.com/it/informativa-sulla-privacy-candidatisito/
