What to Expect Conduct regulatory impact assessments for product changes, including determination of letter-to-file versus submission requirements. Manage annual registrations, license renewals, and ongoing regulatory notifications. Support the preparation, submission, and maintenance of FDA dossiers and related technical documentation. Coordinate the collection, review, and consolidation of data...
Un'agenzia per il lavoro cerca un Regulatory Affairs Specialist per un'azienda nel settore metalmeccanico a Villafranca di Verona. La risorsa si occuperà di sviluppare e gestire i fascicoli tecnici per dispositivi medici secondo la normativa MDR, gestire adempimenti regolatori e supervisione della marcatura CE. Sono richieste competenze in ruoli regolatori e una conoscenza approfondita della...
Join Our Team at HuFriedyGroup – Innovating Excellence in Dental Instrument Manufacturing HuFriedyGroup is a leading manufacturer of dental instruments and infection prevention products. Our 10,000-plus products, hand-crafted by highly skilled artisans, are known for their precision, performance, longevity, reliability, and quality. To help dental professionals be The Best in Practice,...
Mission Overview We are seeking an experienced Temporary Project Manager to lead, on a day-to-day basis, the definition, execution, and monitoring of a comprehensive regulatory compliance action plan for EU Class II and Class III medical device technical documentation. Operating in a high-pressure and time-critical environment, the Project Manager will play a pivotal role in ensuring full...
Job Overview Hantech Medical specializes in Contract R&D and Manufacturing services of medical consumables and innovation of medical core components. About This Role The Quality Manager is responsible for ensuring quality assurance and regulatory affairs activities for our organization. Duties include defining processes, monitoring their application throughout the organization, organizing...
A medical technology company located in Villamarzana is in search of a Quality Manager. The successful candidate will oversee Quality Assurance and Regulatory Affairs for the organization, ensuring compliance with EU and FDA standards. This role requires at least 5 years of experience in Quality Management Systems, strong project management skills, and fluency in English. Responsibilities include...
Clinical Trial Educator – Europe Location: Remote, Europe Industry: Biopharmaceutical / Clinical Development Therapy Area - Rare disease About the Role We are seeking an experienced Clinical Trial Educator (CTE) to support clinical development programs across Europe. This position offers the opportunity to work directly with leading investigators and study sites, helping to ensure excellence in...
FOR MORE THAN 80 YEARS, Natus has been working in collaboration with clinicians to deliver industry-leading neuro solutions that help providers more easily make sense of the body's signals. Engineered with input from those who have lived the care experience, our technology simplifies complex processes and improves accuracy and efficiency. There is a role for everyone who wants to be part of the...
MAW – Divisione Search and Selection è alla ricerca, per importante ed innovativa realtà operante nel settore Biomedicale , una figura di: REGULATORY AFFAIRS COORDINATOR La risorsa, sarà responsabile del coordinamento delle attività di un team dedicato alle attività regolatorie, garantendo la conformità dei dispositivi medici alle normative vigenti sui mercati nazionali e internazionali. Attività...
Our client is Argenx, a fast-growing global immunology company committed to improving the lives of people suffering from severe autoimmune diseases. Thanks to colleagues based in Europe, the United States and Japan, Argenx translates immunology breakthroughs into a world-class portfolio of novel antibody-based medicines. Argenx is preparing for multi-dimensional expansion to reach more patients...
Grafton LifeScience è la specializzazione di Gi Group dedicata a valorizzare le esperienze, le competenze e il potenziale dei candidati in ambito Sales&Marketing, Clinical Research, Regulatory e Operation dei settori Farmaceutico e Medicale e per le mansioni legate all'assistenza al cliente del mondo distributivo con impatto sulla salute. Il nostro cliente è una multinazionale leader nel settore...
Job Overview We are seeking a seasoned professional to lead our regulatory compliance initiative for EU Class II and Class III medical device technical documentation. This high-pressure role demands daily planning, coordination, and execution of the compliance action plan. The successful candidate will ensure timely progress against defined objectives and regulatory deadlines while coordinating...
Therapeutic Area Manager, Oncology, Triveneto Field based Reports to Regional Sales Manager Solid Tumours The Opportunity Menarini Stemline is searching for an experienced Key Account Manager from the biotech space who thrives on high-level scientific exchange and the sense of reward achieved from bringing first-in-class treatments to patients and the impact this has on their and their families'...
Our client is Argenx, a fast-growing global immunology company committed to improving the lives of people suffering from severe autoimmune diseases. Thanks to colleagues based in Europe, the United States and Japan, Argenx translates immunology breakthroughs into a world-class portfolio of novel antibody-based medicines. Argenx is preparing for multi-dimensional expansion to reach more patients...
Randstad Talent Selection è la Specialty che si occupa di Ricerca & Selezione di professionisti qualificati.Per azienda del territorio specializzata nella produzione di dispositivi medici, stiamo cercando un:RESPONSABILE REGOLATORIO/REGULATORY AFFAIRS MANAGERRetribuzione annua: *****€ - *****€esperienzada 3 a 5 anniSiamo alla ricerca di una figura in possesso dei seguenti requisiti:Laurea ad...
We offer an interesting opportunity to join our Quality team, based in Bussolengo (VR) as Quality Management System Specialist, reporting to the Quality Management System Manager, on a full-time permanent contract. The person is part of Quality Team and it contributes to maintain live and in compliance the Quality Management System implemented in European Subsidiaries. He/She aims to ensure that...
Job Title: Scientific Writing Lead (Italian Speaking) Who are we? We are a technology-led healthcare solutions provider. We are driven by our purpose to enable healthcare organizations be future ready. We offer accelerated, global growth opportunities for talent that's bold, industrious, and nimble. With Indegene, you gain a unique career experience that celebrates entrepreneurship, and is guided...
Posizione : Regulatory Manager – Settore Medicale Sede di lavoro : Provincia di Vicenza (zona nord) Manpower Permanent Professional, per conto di una solida e strutturata realtà metalmeccanica operante nel settore medicale, seleziona un / a Regulatory Manager con esperienza nel ruolo, da inserire in un contesto dinamico e in continua evoluzione. Responsabilità principali : Garantire la conformità...
Hantech Medical ( is specialized in Contract R& D and Manufacturing services of medical consumables and innovation of medical core components. Our products range from interventional catheters and related consumables, infusion and drug delivery system consumables, dental consumables, diabetes treatment consumables and epidemic prevention products. For our site in Villamarzana (Rovigo), Hantech...
Alchimia is one of the leading European manufacturers of medical devices for ophthalmic surgery and tissue banks. With our expertise in the fields of chemistry, microbiology, and pharmacology, at Alchimia we have adopted this rule: we design each medical device as if it were intended for ourselves. This allows us to offer safe, useful, and effective solutions to improve the daily operations of...