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 2 giorni fa
Offerte di lavoro simili
- Un'azienda del settore medicale in Veneto cerca un Healthcare Advisor per sviluppare il fatturato e assistere l’equipe medica in sala operatoria. La posizione richiede una laurea in ingegneria, economia, infermieristica o discipline scientifiche, oltre a ottime capacità...MedicaleTempo pienoDal lunedì al venerdì
- ...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
- ph3POSITION SUMMARY: /h3pThe Clinical Specialist delivers professional... ...member of the Clinical and Medical Affairs (CMA) team, this position... ...mastery related to medical devices and urology experience preferred... ...and other international regulatory requirements. /li /ulpbBudgeted...MedicaleTurno di notte
- ...Overview In this senior regulatory role, you provide strategic... ...the lifecycle of Illumina's medical devices, diagnostics, and life-science... ...Interpret EU and UK medical device and IVD frameworks, country-... ...obligations with Regulatory Affairs and Quality Advise on regulatory...MedicaleOrario flessibile
18.808 €
...POSITION SUMMARY: The Clinical Specialist delivers professional... ...member of the Clinical and Medical Affairs (CMA) team, this position will... ...mastery related to medical devices and urology experience preferred... ...and other international regulatory requirements. Budgeted Salary...MedicaleTurno di notte- ...first to pioneer and holds the top position in the Tap on Any Device technology, enabling payments acceptance on any device or even... ...comprehensive benefits package in addition to salary (Allowances, group medical plan coverage, etc). The opportunity to work with a highly...MedicaleImpiego permanente
- pFidia Farmaceutici is seeking a Medical Representative for Specialty Care in Italy. The role involves presenting scientific information to health professionals, collecting product feedback, and maintaining up-to-date records. /ppYou will work with local teams to drive...Medicale
- ...and semiconductor chips - the brains of devices we use every day. As the foundation of the... ...for a Technical Trade Compliance Specialist to join our EMEA Trade Compliance team.... ...requirements, sanctions regulations, and local regulatory obligations. /liliSupport the...Tempo pienoLavoro da casa
- ...aziendali Assicurare la miglior attività sui diversi target Medici in linea con le priorità Aziendali (call plan con frequenza -... ...Funzioni aziendali (Sales, Marketing, Business Operations, Medical Affairs, Responsabile Servizio Scientifico Medici di medicina generale...Medicale
- ...Role: Pharmacovigilance Specialist (Remote) Location: Remote (Work from Anywhere)... ...products to ensure patient safety and regulatory compliance. The position requires meticulous... ...cross-functional teams, including medical affairs and regulatory affairs, to evaluate safety...MedicaleTempo pienoRemoto
- ...for one of our clients, seeking a Strategic Project Lead, MD/Medical Expertise to work on a full-time basis. This role requires a medical... ...and mitigate risks related to project timelines, budgets, and regulatory compliance. Coordinate with medical teams to ensure...MedicaleTempo pienoRemoto
- ...full lifecycle: idea → launch → scale Translate clinical, regulatory, and market requirements into clear strategic roadmaps Lead... ...execution Collaborate across strategy, account, data, technology, medical, and commercial teams You will bring Strong experience...Medicale
- ...interprofessional collaboration. More About the Opportunity: This role offers a unique opportunity to work with a global leader in the Medical Practices industry, contributing to improved patient outcomes through advanced oncology and hematology care. The position is fully...MedicaleTempo pienoRemotoOrario flessibile
- ...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
- ...commerciali sul territorio grazie alla collaborazione con la nostra forza vendita. /ppDovrai garantire presenza ed assistenza all’equipe medica in sala operatoria durante l’utilizzo dei nostri dispositivi medici e delle apparecchiature. Lavorerai in un ambiente professionale...MedicaleTempo pienoDal lunedì al venerdì
30.000 € - 35.000 €
...basis of ethnic origin, skin color, religion, civil status, age, nationality, ancestry, any form of disability or neurodivergence, medical condition, gender, gender identity or expression, sexual orientation. We celebrate diversity and are committed to creating an inclusive...Medicale25.000 € - 30.000 €
...basis of ethnic origin, skin color, religion, civil status, age, nationality, ancestry, any form of disability or neurodivergence, medical condition, gender, gender identity or expression, sexual orientation. We celebrate diversity and are committed to creating an inclusive...MedicaleTurni- ...Develop a deep understanding of the territory, competitive landscape and patient pathways. Work cross-functionally with Medical Affairs, Marketing and Market Access. Identify and address barriers to patient access at regional and hospital level. Engage with...MedicaleOrario flessibile
- ...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
- ...An exciting oncology launch opportunity! Senior Medical Science Liaison Manager (F/M/X) Italy Our client is a pioneering oncology... ...Liaison Manager (F/M/X) to support the expansion of its Medical Affairs organization in Italy and contribute to the preparation of a...MedicaleLavoro da casa
- ...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
- ...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
- ...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
- ...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
- ...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
- ...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