Regulatory Affairs Associate – Medical Device Italy

7 giorni fa


italia Resourcing Life Science A tempo pieno

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 for international regulatory registrations. Collaborate with global Regulatory Affairs partners and cross-functional stakeholders to ensure timely, compliant submissions. Execute administrative, documentation, and procedural activities supporting the Regulatory Affairs function. Requirements Bachelor degree Min 4 years of experience in Regulatory Affairs in the medical device Proven experience with global submissions, preferably including FDA, Excellent communication and problem-solving skills Fluent in English (written and spoken). If you have difficulty in applying, have any questions or you cannot find what you are looking for please contact us on 0044 (0) or email #J-18808-Ljbffr



  • italia Resourcing Life Science A tempo pieno

    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...


  • italia Allergan A tempo pieno

    Company Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and...


  • Italia, IT TS Quality & Engineering A tempo pieno

    We are expanding our commercial team and looking for a Sales & Business Development professional with experience in the Medical Device and/or Pharmaceutical sector consulting Countries in scope: Italy | Switzerland | UK | Ireland About TSQE TSQE supports Medical Device and Pharmaceutical companies throughout the entire product lifecycle , providing...


  • Italia Barilla A tempo pieno

    About BarillaAt Barilla, we believe that every great journey begins with passion and a bold vision. From our humble beginnings in 1877 in a small shop in Parma, Italy, we've blossomed into a global leader in the food industry, guided by our commitment to progress and excellence.Today, Barilla is an international group present in more than 100 countries and...

  • Line Manager

    7 giorni fa


    italia Resourcing Life Science A tempo pieno

    What to Expect Line management, training of Regulatory Specialist Training of the direct reports in EMEA / FDA requirements Establish and manage regulatory submission timelines for both new and existing products across key global markets Engage with regulatory authorities and distribution partners to support product registrations Conduct global regulatory...

  • Line Manager

    7 giorni fa


    italia Resourcing Life Science A tempo pieno

    What to Expect Line management, training of Regulatory Specialist Training of the direct reports in EMEA / FDA requirements Establish and manage regulatory submission timelines for both new and existing products across key global markets Engage with regulatory authorities and distribution partners to support product registrations Conduct global regulatory...


  • Italia, IT Ecupharma Srl A tempo pieno

    Pharma Point, per conto di Ecupharma, azienda farmaceutica con un solido portafoglio di prodotti nelle aree terapeutiche specialistiche del SNC, urologica e cardiovascolare, è alla ricerca di un/a: Regulatory Affairs Specialist. La figura sarà inserita nel team di Regulatory Affairs e risponderà direttamente al Head of RA. Responsabilità Mantenimento...


  • Italia Amway A tempo pieno

    Amway is the world's #1 direct selling company and one of the largest family-owned businesses globally. Since 1959, we've been empowering people with innovative solutions and over 450 premium products in nutrition, beauty, and home care. Sold exclusively through our network of independent distributors and our webshop, our products help millions live...


  • italia Life Sciences WA A tempo pieno

    A leading clinical research organization in Italy seeks a Clinical Research Associate. The role involves managing investigator recruitment, ensuring regulatory compliance, and monitoring clinical sites. Candidates should have excellent communication skills and a thorough understanding of clinical trial processes. This position offers a supportive and...


  • Italia Synergie Italia A tempo pieno

    Synergie Italia Spa, filiale di Monza, seleziona per azienda cliente produttrice di principi attivi farmaceutici, una figura di: REGULATORY AFFAIRS SPECIALIST In qualità di Regulatory Affairs Specialist, verrai inserita/o nel team dedicato agli Affari Regolatori e supporterai le attività legate alla gestione della documentazione tecnica e regolatoria...