Regulatory & Product Compliance Specialist Medical Device
4 giorni fa
Per un azienda multinazionale attiva nel settore dei dispositivi medici e diagnostici in vitro ricerchiamo una figura dedicata alla Product Compliance. Ruolo e responsabilità Lobiettivo della risorsa è garantire che i dispositivi medici siano in conformità alle normative e agli standard internazionali. Ciò include la gestione delle procedure di marcatura CE e di autorizzazione presso US-FDA. Nello specifico la risorsa si occuperà di : Gestione e aggiornamento della documentazione tecnica per Marcatura CE IVDR e MDR applicabile Gestione dossier di registrazione presso US-FDA compresa la gestione delliter di revisione da parte dellautorità Collaborazione con il dipartimento di Product Design per le fasi di sviluppo del prodotto Redazione dossier di valutazione del rischio biologico Interfaccia con le Autorità Competenti e gli Enti Designati in fase di audit Requisiti Il profilo ricercato ha : Laurea in discipline scientifiche (Farmacia Biotecnologie Biologia o affini); Esperienza di almeno 1 anno in Regulatory Affairs in aziende certificate di dispositivi medici o IVD; Conoscenza dellinglese fluente Ottima padronanza di Office e strumenti informatici; Precisione affidabilità e orientamento al risultato. Cosa avrai Assunzione a tempo indeterminato con CCNL Chimico Farmaceutico e retribuzione commisurata allesperienza. Sede di lavoro Brescia con 1 giorno di Smart Working a settimana Key Skills Sales Experience, Marketing, Customer Service, Communication skills, Military Experience, Retail Sales, Product Demos, Customer Support, Product Management, Product Development, Unity, Microscopy Employment Type : Full Time Experience : years Vacancy : 1 #J-18808-Ljbffr
-
Medical Device Regulatory
4 giorni fa
WorkFromHome, Italia Professional Recruitment A tempo pienoUn'azienda multinazionale nel settore dei dispositivi medici cerca una figura per la Product Compliance. Responsabilità principali includono la garanzia di conformità normativa e gestione della documentazione per Marcatura CE e autorizzazione US-FDA. Si richiedono laurea in discipline scientifiche e almeno 1 anno di esperienza in Regulatory Affairs....
-
Remote Medical Device QA
2 giorni fa
WorkFromHome, Italia SGS A tempo pienoA leading global testing and certification company is seeking a Quality Assurance professional for a remote position focused on managing the internal quality management system for medical devices. Responsibilities include updating and maintaining compliance documents, managing queries, and supporting continual improvement processes. Candidates should have a...
-
Medical Device QMS Audit Manager
1 settimana fa
WorkFromHome, Italia SGS A tempo pienoCompany Description and Location: SGS is the world’s leading testing, inspection and certification company, recognised as the global benchmark for sustainability, quality and integrity. 44,000 employees operate 2,500 offices and laboratories worldwide, enabling a safer and more interconnected world. The role is Remote within Europe. We are seeking a...
-
Medical Device QMS Audit Manager
6 giorni fa
WorkFromHome, Italia SGS A tempo pienoWe are seeking a knowledgeable and driven Medical Device QMS Audit Manager to lead and oversee the training qualification and compliance processes for QMS Auditors involved in our medical device conformity assessments. This non-clinical role plays a vital part in ensuring the competence of technical personnel and the continued regulatory compliance of SGS...
-
Regulatory Manager
2 settimane fa
WorkFromHome, Italia SGS A tempo pienoOverview We are seeking a highly skilled Regulatory Manager to oversee the clinical and performance evaluation components of our medical device conformity assessment process within Notified Body 1639. This role is vital to ensuring regulatory excellence, clinical integrity and the delivery of high-quality assessments aligned with MDR and IVDR. Your Mission...
-
Regulatory Manager
1 settimana fa
WorkFromHome, Italia SGS A tempo pienoOverview We are seeking a highly skilled Regulatory Manager to oversee the clinical and performance evaluation components of our medical device conformity assessment process within Notified Body 1639. This role is vital to ensuring regulatory excellence, clinical integrity and the delivery of high-quality assessments aligned with MDR and IVDR. Your Mission...
-
Sr Specialist, Global Regulatory Affairs
4 giorni fa
WorkFromHome, Italia Herbalife International, Inc. A tempo pienoSr Specialist, Global Regulatory Affairs Herbalife Italy – Rome Via Amsterdam, 125 Roma00144 About the role We’re looking for an experienced Senior Specialist, Global Regulatory Affairs to join our dynamic Global Regulatory Affairs team, supporting the Europe & Africa (E&A) sub-region. This role is based in Rome, Italy and plays a key part in ensuring...
-
Remote Medical Device QMS Audit Lead
6 giorni fa
WorkFromHome, Italia SGS A tempo pienoA global leader in inspection and certification is seeking a knowledgeable Medical Device QMS Audit Manager to oversee training and compliance for QMS Auditors. You will develop training frameworks and ensure qualification criteria are met while providing expert guidance across conformity assessments. Ideal candidates will have 10+ years of experience in the...
-
Europe NV+ Clinical Sales Specialist
3 settimane fa
WorkFromHome, Italia NEUROVISION MEDICAL PRODUCTS, INC. A tempo pienoA leading medical technology company is seeking a Product Sales & Clinical Specialist to manage product integration of the NV+ system across Europe. The ideal candidate will have a degree in biomedical sciences and 2+ years of experience in clinical support or surgical device sales, along with strong communication skills. This role is hybrid and requires...
-
Remote Global Planning Lead — Medical Devices
3 settimane fa
WorkFromHome, Italia SGS A tempo pienoA global leader in TIC is seeking a Planning Team Leader to oversee planning operations within its Medical Services. The role requires strong leadership and a deep understanding of regulatory compliance, resource planning, and financial performance optimization. Candidates must have a degree in a relevant field, extensive experience in the medical device...