Regulatory Affairs Specialist

6 mesi fa

Provincia di Milano Lombardia, Italia Instrumentation Laboratory spa A tempo pieno

For our Clinical Chemistry Strategic Business Unit, based in Milan (Italy), we are looking for a:
**Regulatory Affairs Specialist - Maternity Leave**:
The Regulatory Affairs Specialist handles the Regulatory Affairs activities in the pre-market.

The main accountabilities of the Regulatory Affairs Specialist are:
Support registrations, understand the local requirements and collect the documents and information required by local authorities in EU;
Provide regulatory support on tender requests in EU territories;
Be the reference contact for EU Affiliates and Distributors for Regulatory Affairs issues;
Study and actively monitor the Regulatory requirements in EU;
Give support for product notifications in Repertorio database in Italy;
Participate to associations working groups and activities (Confindustria, Medtech, etc.).

At least 1 year of experience in the same role, in a Medical Devices or In Vitro Diagnostic Devices Company is preferred.
Knowledge of European Regulation applicable to Medical Devices and/or in Vitro Diagnostic Devices is preferred
Passion for the comprehension of the business.
Good attitude for analysis and synthesis.
Fluent knowledge of English.

**IT skills**: Office, SAP

Organization and time management
Precision and attention to details
Team working
Communication
Problem solving
Flexibility

At Werfen, worldwide leader in the in vitro diagnostics market, consideration and enhancement of people are a key factor for growth and success for the entire company. The possibility of working in an international organization, the quality of interpersonal relationships, the constant attention to people and the possibility to emerge and grow professionally are some of the main elements that characterize our corporate culture. We want people to choose to work in Werfen because they share our same values.

Are you the person we are looking for?

Send us your resume or CV and join the Werfen Team

  • Regulatory Affairs Specialist Italy Milan

    6 mesi fa

    Provincia di Milano, Lombardia, Italia GXPeople A tempo pieno

    : Quality Assurance **Posizione: Regulatory Affairs & Clinical Specialist** **Location: Milano provincia (on-site)** **Retribuzione: commisurata all'effettiva esperienza** Siamo alla ricerca di un Regulatory Affairs & Clinical Specialist per conto di un'azienda storica, basata in provincia di Milano. Si tratta di un'azienda fabbricante di Medical...

  • Cosmetic Regulatory Affairs Specialist

    6 mesi fa

    Provincia di Milano, Lombardia, Italia Ganassini Corporate A tempo pieno

    Il gruppo Ganassini cerca un/a Cosmetic Regulatory Affairs Specialist La risorsa inserita lavorerà a stretto contatto con Cosmetic Regulatory Affair Manager, occupandosi principalmente di: redigere Product Information File (PIF); collaborare con fornitori per la raccolta di documentazione relativa a materie prime e packaging; verificare che ogni prodotto...

  • Regulatory Affairs Specialist

    3 settimane fa

    Milano, Lombardia, Italia Hover Senior Living Community A tempo pieno

    Job SummaryThe Regulatory Affairs Senior Specialist will be supporting the implementation, execution and management of the local regulatory activities in Italy ensuring regulatory compliance with local regulatory requirements and corporate policies.The Regulatory Affairs Senior Specialist supports interactions with the national Regulatory Authorities, i.e....

  • Medical Device Regulatory Affairs Specialist

    2 mesi fa

    Provincia di Milano, Lombardia, Italia Ganassini Corporate A tempo pieno

    Il gruppo Ganassini cerca un/a Medical Device Regulatory Affairs Specialist La persona si occuperà di supportare il Regulatory Affairs Manager e la Direzione Tecnica in tutte le attività regolatorie sui dispositivi medici a base di sostanze.Dovrà essere in grado di gestire autonomamente la preparazione dei fascicoli tecnici dei prodotti. **Obiettivi...

  • Cosmetic Regulatory Affairs Specialist

    5 mesi fa

    Provincia di Milano, Lombardia, Italia Ganassini Corporate A tempo pieno

    Il gruppo Ganassini cerca un/a Cosmetic Regulatory Affairs Specialist - Testing La risorsa inserita lavorerà a stretto contatto con Cosmetic Regulatory Affair Manager, occupandosi principalmente di: Definizione di protocolli sperimentali di efficacia e sicurezza adottati per effettuare test su prodotti cosmetici. Analisi statistica dei dati ottenuti...

  • Regulatory Affairs Specialist Eu

    6 mesi fa

    Milano, Italia Clinglobal Group A tempo pieno

    **Regulatory Affairs Specialist - European Union** Clinglobal is an Animal Health Contract Research Organisation and supports our global operations in various countries. We are currently looking for a** Regulatory Affairs Specialist** based in the EU to join our growing Regulatory Affairs team at Clinglobal. This position offers the opportunity to work...

  • Senior Specialist

    4 mesi fa

    Milano, Italia Hover Senior Living Community A tempo pieno

    Regulatory Affairs Senior Specialist Reports to: Director, Italy Regulatory Affairs and Quality Location: Milan, Italy Position Summary The Regulatory Affairs Senior Specialist will be supporting the implementation, execution and management of the local regulatory activities in Italy ensuring regulatory compliance with local regulatory requirements and...

  • Regulatory Affairs Specialist

    3 settimane fa

    Milano, Lombardia, Italia Recordati A tempo pieno

    Job DescriptionRecordati is seeking a highly skilled Regulatory Affairs Specialist to join its international team. As a key member of the Corporate Regulatory Affairs department, you will be responsible for the management of regulatory activities for medicinal products for human use.Key Responsibilities:Preparation, review, and submission of relevant...

  • Junior Regulatory Affairs Specialist

    2 settimane fa

    Provincia di Reggio nell'Emilia, Italia Human Bio Care A tempo pieno

    Azienda produttrice di kit biomedicali seleziona una figura per il ruolo di Junior Regulatory Affairs Specialist che si occuperà delle seguenti attività: Assicurare l’aggiornamento e il rispetto delle normative, procedure ed istruzioni operative in vigore; Partecipare alle verifiche ispettive di Ente Notificato e interne; Assicurare la corretta...

  • Regulatory Affairs Specialist for Medical Devices

    2 settimane fa

    Milano, Lombardia, Italia Page Personnel A tempo pieno

    Job SummaryWe are seeking a highly motivated Regulatory Affairs Specialist to support our medical devices team.Main ResponsibilitiesAs a Regulatory Affairs Specialist, you will play a key role in ensuring compliance with regulatory requirements for our medical devices. Key responsibilities include preparing and submitting regulatory submissions to regulatory...

  • Regulatory Affairs Specialist

    4 settimane fa

    Milano, Lombardia, Italia W EXECUTIVE S.R.L. A tempo pieno

    Job Title: Regulatory Affairs ManagerCompany: W EXECUTIVE S.R.L.Location: MilanoAs a Regulatory Affairs Manager at W EXECUTIVE S.R.L., you will be responsible for ensuring that our company's products comply with all relevant laws and regulations. This includes developing and executing regulatory strategies, managing product registrations, and providing...

  • Regulatory Affairs Specialist

    6 mesi fa

    Milano, Italia AstraZeneca A tempo pieno

    **Regulatory Affairs Specialist (maternity leave)** At AstraZeneca we believe in the potential of our people and you’ll develop beyond what you thought possible. We make the most of your skills and passion by actively supporting you to see what you can achieve no matter where you start with us. As **Regulatory Affairs Specialist (maternity leave)** in...

  • International Regulatory Affairs Specialist

    4 mesi fa

    Milano, Italia Recordati A tempo pieno

    Press Tab to Move to Skip to Content Link Select how often (in days) to receive an alert: Select how often (in days) to receive an alert: International Regulatory Affairs Specialist ID: 809 Date of Posting: Jun 28, 2024 Job Family: Regulatory Affairs Job Type: Direct Employee Location: Milano, IT Territory: Shift: Full Time Seniority: Mid-senior With its...

  • Regulatory Affairs Specialist for Medical Devices

    1 settimana fa

    Milano, Lombardia, Italia Page Personnel A tempo pieno

    About the RoleWe are seeking a highly motivated and detail-oriented Regulatory Affairs Specialist to join our team at Page Personnel.

  • Regulatory Affairs Director

    4 settimane fa

    Milano, Lombardia, Italia Cpl Healthcare A tempo pieno

    Job Title: Associate Director, Regulatory Affairs - Medical Device/Post Market SurveillanceJob Type: Full Time, Permanent PositionLocation: HybridRemuneration: Attractive salary and packageCpl Healthcare is seeking an experienced Associate Director, Regulatory Affairs - Medical Device Lifecycle Management to join their team. This role offers a unique...

  • Regulatory Affairs Specialist Medical Devices

    4 settimane fa

    Milano, Lombardia, Italia Page Personnel A tempo pieno

    Regulatory Affairs Specialist Medical DevicesPage Personnel è alla ricerca di un Regulatory Affairs Specialist Medical Devices motivato e dettagliato per unirsi al nostro team. Il Regulatory Affairs Specialist Medical Devices svolgerà un ruolo chiave nell'assicurare la conformità con i requisiti regolatori per i dispositivi medici. Questo individuo...

  • Regulatory Affairs Specialist for Medical Devices

    4 settimane fa

    Milano, Lombardia, Italia Page Personnel A tempo pieno

    Regulatory Affairs Specialist for Medical DevicesWe are seeking a highly motivated and detail-oriented Regulatory Affairs Specialist to support our medical device team. The ideal candidate will have a strong understanding of regulatory requirements and guidelines, including FDA regulations (21 CFR Part 820), ISO 13485, and other applicable standards.Key...

  • Medical Device Regulatory Affairs Specialist

    2 settimane fa

    Lombardia, Italia Ganassini Corporate A tempo pieno

    Il gruppo Ganassini cerca un/a Medical Device Regulatory Affairs Specialist . La persona si occuperà di supportare il Regulatory Affairs Manager e la Direzione Tecnica in tutte le attività regolatorie sui dispositivi medici a base di sostanze. Dovrà essere in grado di gestire autonomamente la preparazione dei fascicoli tecnici dei prodotti. Obiettivi...

  • Regulatory Affairs Specialist/international

    5 mesi fa

    Milano, Italia Recordati Group A tempo pieno

    **The contex/Company description** With its beginnings in a family run pharmacy in Correggio, Italy in the 1920s, Recordati is now a global pharmaceutical force, listed on the Italian stock exchange, with over 4,300 employees. We are a group of like-minded, passionate individuals who go to extraordinary lengths for our partners, customers, investors and...

  • CORPORATE REGULATORY AFFAIRS SPECIALIST

    2 settimane fa

    Lombardia, Italia Flamma spa A tempo pieno

    Flamma Group è un'azienda specializzata nello sviluppo, produzione e commercializzazione di molecole e principi attivi (API) per l'industria farmaceutica. Con Headquarter a Chignolo d'Isola, vicino a Milano, Flamma vanta altri due stabilimenti produttivi in Italia, ad Isso (BG) e Bulciago (LC) e due stabilimenti all'estero, a Philadelphia (USA) e Dalian...