Regulatory Affairs Specialist | Medical Devices
Hays
Overview
In questa posizione, ti occupi di gestire le attività regolatorie per dispositivi medici a livello nazionale ed internazionale, garantendo conformità normativa, sottomissioni e manutenção delle registrazioni. Lavorerai a stretto contatto con sedi estere, distributori e funzioni interne per facilitare l accesso ai mercati e l introduzione di nuovi prodotti. Un ruolo chiave nel monitoraggio dei requisiti normativi e nel supporto a audit e ispezioni. Partecipa a progetti di espansione geografica e sviluppo di prodotti, contribuendo alla strategia di conformità globale dell azienda.
Responsabilità
- Gestire le attività di registrazione e rinnovo dei dispositivi medici
- Predisporre, revisionare e aggiornare la documentazione regolatoria per sottomissioni alle Autorità Competenti Locali
- Coordinare pratiche di registrazione tramite distributori, rappresentanti autorizzati e consulenti regolatori locali
- Monitorare costantemente i requisiti normativi dei Paesi di competenza e valutarne l impatto sul portafoglio prodotti
- Garantire il mantenimento delle autorizzazioni e delle registrazioni esistenti, rispettando le scadenze
- Collaborare con i dipartimenti interni per supportare l introduzione di nuovi prodotti nei mercati internazionali
- Gestire variazioni, aggiornamenti tecnici e modifiche documentali richieste dalle autorità locali
- Supportare audit e ispezioni da enti regolatori e organismi notificati
- Fornire consulenza regolatoria alle funzioni aziendali coinvolte nello sviluppo e commercializzazione
- Partecipare a progetti di espansione geografica e lancio di nuovi prodotti
- Mantenere aggiornati database e sistemi di gestione documentale regolatoria
Requisiti fondamentali
- Laurea in discipline scientifiche
- Esperienza pregressa nel ruolo ≥ 2 anni
- Inglese fluente
- Ottime capacità organizzative e gestione delle priorità, precisione e attenzione ai dettagli
- Capacità di lavorare in team multidisciplinari e contesti internazionali
- Problem solving, orientamento al risultato, proattività e autonomia operativa
- organizzazione
- gestione delle priorità
- precisione
- lavoro in team
- gestione documentale regolatoria
- monitoraggio requisiti normativi internazionali
Offerta di lavoro pubblicata 3 giorni fa
Offerte di lavoro simili
- ...Hantech Medical Italy S.p.A. is seeking a Project Engineer to support customer projects from initiation through implementation at our... ...year of experience in project management or related engineering roles who wish to build a career in medical devices. #J-18808-LjbffrMedicale
- ...Hantech Medical Italy S.p.A. is seeking a Project Engineer to coordinate customer projects from initiation through implementation and... ...engineering or manufacturing and is eager to build a career in project management within the medical device industry. #J-18808-LjbffrMedicale
- pHantech Medical Italy S.p.A. is seeking a Junior RD Engineer to support product development, testing, validation and manufacturing process... ...candidate has around 1 year or more of experience in medical devices, RD, engineering or another technical role, with training and...Medicale
- ...Overview In this role you join our Medical Device Notified Body as an Internal Clinician, bringing clinical expertise to support conformity... ...with cross-functional teams to ensure clinical data meets regulatory expectations and contribute to best-practice guides and...MedicaleTempo pienoRemotoLavoro da casaOrario flessibile
- ph3Project Engineer - Medical Devices /h3 pbHantech Medical Italy S.p.A. | Italy | On-site /b /p h3About Hantech Medical Italy /h3 pHantech Medical Italy S.p.A. is a medical device manufacturing company based in Italy, specializing in bsingle-use medical devices and components...MedicaleRemoto
- ppbHantech Medical Italy S.p.A. | Italy | On-site /b /ph3About Hantech Medical Italy /h3pHantech Medical Italy S.p.A. is a medical device manufacturing company based in Italy, specializing in bsingle-use medical devices and components /b, with expertise in bplastic injection...MedicaleStage/Tirocinio
- ...In this senior regulatory role, you provide strategic legal guidance... ...the lifecycle of Illumina’s medical devices, diagnostics, and life-... ...Interpret EU and UK medical device and IVD frameworks, country-... ...obligations with Regulatory Affairs and Quality Advise on regulatory...MedicaleOrario flessibile
- ...Project Engineer – Medical Devices Hantech Medical Italy S.p.A. | Italy | On-site About Hantech Medical Italy Hantech Medical Italy S.p.A. is a medical device manufacturing company based in Italy, specializing in single-use medical devices and components ,...MedicaleTempo pienoRemoto
- ...Hantech Medical Italy S.p.A. | Italy | On-site About Hantech Medical Italy Hantech Medical Italy S.p.A. is a medical device manufacturing company based in Italy, specializing in single-use medical devices and components , with expertise in plastic injection molding...MedicaleStage/Tirocinio
- ...group with a strong patient focus. /pullipension /liliprivate medical insurance /liliremote work options /liliLead program strategy... ...risk mitigation, CAPAs, and inspection readiness /liliSupport regulatory documentation (eCTD, CSR/CIR) and registry submissions /liliSupport...Medicale
- ...in a global, science-driven environment with a clear impact on patient outcomes. Retribuzione / Benefits pension private medical insurance wellbeing programme flexible benefits programme relocation support remote work options Responsabilità ~...MedicaleRemoto
- ...impact on supply chain performance and business outcomes. Retribuzione / Benefits Hybrid work model Annual bonus Private medical insurance Life insurance Eye-glass refund Internal reward system (E-Stars) Responsabilità Support the monthly SIOP...MedicaleLavoro ibrido
- ...Overview In this role you will support worldwide post-approval regulatory activities focused on CMC for vaccines or biological products.... ...in Life Sciences or equivalent Experience in regulatory affairs, especially technical/CMC/quality in pharma Strong...Orario flessibile
- ...align R&D and commercial goals, shape trial designs, and drive regulatory success with high scientific and operational impact. You... ...development, succession planning, and leadership forums Provide medical and scientific leadership across all phases of clinical trials...MedicaleRemotoOrario flessibile
- ...outsourced activities, ensure data quality, and contribute to regulatory documentation. This position offers impact in shaping analytics... ...environment. Retribuzione / Benefits pension private medical insurance wellbeing programme flexible benefits...MedicaleStage/TirocinioRemoto
- ...This position offers hands-on field work across Italy with significant travel and shift flexibility, contributing to cutting-edge medical imaging innovation. Responsabilità Install new MRI systems Perform periodic maintenance and system repairs Provide technical...MedicaleRemotoTurniTurno di pomeridianoTurno di notte
- ...launch. You will shape transfer strategies, ensure quality and regulatory readiness, and guide lifecycle improvements. This role offers... ...Retribuzione / Benefits annual bonus scheme pension private medical insurance wellbeing programme flexible benefits...Medicale
- ...for Chiesi's Air/Care and Rare products, partnering with R&D, regulatory, manufacturing and quality teams to drive proactive lifecycle... ...growing portfolio. Retribuzione / Benefits pension private medical insurance wellbeing programme flexible benefits...MedicaleRemoto
- ...within a mission-driven, sustainability-oriented company. Retribuzione / Benefits annual bonus scheme pension private medical insurance wellbeing programme flexible benefits programme remote work options Responsabilità Develop and maintain global...MedicaleRemoto
- ...collaboration across a global team and opportunities to shape rare-disease trials. Retribuzione / Benefits pension private medical insurance wellbeing programme flexible benefits programme relocation support remote work options Responsabilità...MedicaleRemoto
- ...In this role you coordinate the operational management of assigned clinical projects to advance Chiesi's pipeline in line with medical standards. You act as the primary liaison to CROs, providers, and internal stakeholders, ensuring study quality, timelines, and budget...MedicaleRemoto
- ...patient impact. Retribuzione / Benefits pension private medical insurance wellbeing programme flexible benefits... ...Collaborate with cross-functional stakeholders (BD, GMA, GVA, R&D, Regulatory, CMC, IP, Finance) Translate insights into actionable commercial...MedicaleRemoto
- ...functional execution, shaping partnerships and data sourcing to inform regulatory, payer, and clinical decisions. You'll advance innovative... ...diseases. Retribuzione / Benefits pension private medical insurance wellbeing programme flexible benefits...MedicaleRemoto
- ...hands-on innovation at scale with meaningful, real-world health impact. Retribuzione / Benefits flexible time off private medical insurance pension employee stock purchasing program volunteer time off summer shutdown Responsabilità Design and...MedicaleOrario flessibile
- ...assigned products, shaping proactive risk management and safety surveillance. You collaborate across Clinical Development, Medical Affairs, Regulatory, Quality and external partners to integrate safety data into development plans and submissions. You drive science-led...MedicaleStage/TirocinioAuto aziendale
- ...offers remote work within ABB's Electrification Services Division in the United States and a clear,跨 Retribuzione / Benefits ~ medical plan options ~ dental plan options ~ vision benefit ~ company paid life insurance ~ short-term disability ~401k savings...MedicaleRemoto
- ...Retribuzione / Benefits annual bonus scheme pension private medical insurance wellbeing programme flexible benefits... ...Experience in Pharmaceutical R&D or Life Sciences domain and regulatory needs preferred Proven hands-on solution design in complex...MedicaleRemoto
- ...responsibilities such as SOP reviews and organizational initiatives Requisiti fondamentali Bachelor's degree in a science or medical field (or substantial clinical project management experience) CRO experience with Phase I–III clinical trial management Strong...MedicaleRemoto
- ...Guide development of pharmaco-economic data and budget impact models Establish relationships with Regional Health Authorities, Medical Societies, procurement bodies and payers focusing on access and evidence-based decisions Communicate changes and trends in local...Medicale
- ...Overview As a Senior Regulatory Affairs Associate, you will drive post-approval regulatory activities focused on CMC for biological and vaccine products. You will collaborate across manufacturing, QA, QC, and regulatory teams to shape submission strategies and ensure...RemotoOrario flessibile
Ricerche correlate
- medicale Rovigo (Provincia di Rovigo)
- piu medical Rovigo (Provincia di Rovigo)
- aziende medicali Rovigo (Provincia di Rovigo)
- agenti settore medical Rovigo (Provincia di Rovigo)
- medical information Rovigo (Provincia di Rovigo)
- beauty consultant canale farmacia e medicale
- smiths medical
- medicale
- medical communication
- ossigeno medicale