Lavori attuali relativi a Ra Specialist Medical Devices - Milano - Tn Italy

  • Ra Specialist Medical Devices

    2 mesi fa

    Milano, Italia Page Personnel A tempo pieno

    - RA Specialist Medical Devices - Medical company that develops Class III, II and I devices Il nostro clienteMedical company that develops Class III, II and I devicesRuoloWe are seeking a highly motivated and detail-oriented Regulatory Affairs Specialist to join our team.

  • Ra Specialist Medical Devices

    2 mesi fa

    Milano, Italia Page Personnel A tempo pieno

    We are seeking a highly motivated and detail-oriented Regulatory Affairs Specialist to join our team.The Regulatory Affairs Specialist will play a key role in ensuring compliance with regulatory requirements for our medical devices.This individual will collaborate cross-functionally with internal teams to support product development, registration, and...

  • Ra Specialist Medical Devices

    2 settimane fa

    Milano, Italia Page Personnel A tempo pieno

    We are seeking a highly motivated and detail-oriented Regulatory Affairs Specialist to join our team.The Regulatory Affairs Specialist will play a key role in ensuring compliance with regulatory requirements for our medical devices.This individual will collaborate cross-functionally with internal teams to support product development, registration, and...

  • Ra Specialist Medical Devices

    1 mese fa

    Milano, Italia Page Personnel A tempo pieno

    Il nostro cliente Medical company that develops Class III, II and I devices La figura ricercata We are seeking a highly motivated and detail-oriented Regulatory Affairs Specialist to join our team. The Regulatory Affairs Specialist will play a key role in ensuring compliance with regulatory requirements for our medical devices. This individual will...

  • Ra Specialist Medical Devices

    2 mesi fa

    Milano, Italia Page Personnel A tempo pieno

    Il nostro cliente Medical company that develops Class III, II and I devices La figura ricercata We are seeking a highly motivated and detail-oriented Regulatory Affairs Specialist to join our team. The Regulatory Affairs Specialist will play a key role in ensuring compliance with regulatory requirements for our medical devices. This individual will...

  • Design Control Specialist

    5 mesi fa

    Milano, Italia IQVIA A tempo pieno

    Our client, **Chiesi Farmaceutici **- one of the top 50 pharmaceutical companies in the world, with more than 80 years of experience within the pharmaceutical and biotechnology industry - in order to expand their staff, entrusted to IQVIA the recruitment of **Design Control Specialist - Medical Devices - **who can join an exciting working environment in a...

  • Design Control Specialist

    5 mesi fa

    Milano, Italia Novasyte A tempo pieno

    Our client, Chiesi Farmaceutici - one of the top 50 pharmaceutical companies in the world, with more than 80 years of experience within the pharmaceutical and biotechnology industry - in order to expand their staff, entrusted to IQVIA the recruitment of Design Control Specialist - Medical Devices - who can join an exciting working environment in a dynamic...

  • Tender Specialist

    5 giorni fa

    Milano, Lombardia, Italia Jotec Gmbh A tempo pieno

    We are seeking a skilled Tender Specialist (Medical Devices) to join our team at Jotec Gmbh, a subsidiary of Artivion, Inc. In this role, you will be responsible for researching, identifying, and analyzing tender notices to discover potential business opportunities. Your responsibilities will also include drafting procurement contracts, building partnerships...

  • Regulatory Affairs Specialist for Medical Devices

    3 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 team in ensuring compliance with regulatory requirements for our medical devices.Prepare and submit regulatory submissions to regulatory authorities, including 510(k) premarket notifications, Technical Files,...

  • Regulatory Affairs Specialist for Medical Devices

    2 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 play a key role in ensuring compliance with regulatory requirements for our medical devices.This individual will collaborate cross-functionally with internal teams to support product development, registration, and...

  • Regulatory Affairs Specialist for Medical Devices

    2 giorni 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 Medical Devices

    3 settimane fa

    Milano, Lombardia, Italia Page Personnel A tempo pieno

    Regulatory Affairs Specialist Medical DevicesWe are seeking a highly motivated and detail-oriented Regulatory Affairs Specialist to support our medical device team.Key Responsibilities:Prepare and submit regulatory submissions to regulatory authorities, including 510(k) premarket notifications, Technical Files, Design Dossiers, and other regulatory filings...

  • Regulatory Affairs Specialist Medical Devices

    1 mese fa

    Milano, Lombardia, Italia Page Personnel A tempo pieno

    Regulatory Affairs Specialist Medical DevicesWe are seeking a highly motivated and detail-oriented Regulatory Affairs Specialist to support our medical device team. The successful candidate will play a key role in ensuring compliance with regulatory requirements for our medical devices.Key Responsibilities:Regulatory Submissions: Prepare and submit...

  • Regulatory Affairs Specialist Medical Devices

    4 settimane fa

    Milano, Lombardia, Italia Page Personnel A tempo pieno

    Regulatory Affairs Specialist Medical DevicesWe are seeking a highly motivated and detail-oriented Regulatory Affairs Specialist to support our medical device team. The successful candidate will play a key role in ensuring compliance with regulatory requirements for our medical devices.Key Responsibilities:Regulatory Submissions: Prepare and submit...

  • Regulatory Affairs Specialist Medical Devices

    4 settimane fa

    Milano, Lombardia, Italia Page Personnel A tempo pieno

    Regulatory Affairs Specialist Medical DevicesWe are seeking a highly motivated and detail-oriented Regulatory Affairs Specialist to join our team at Page Personnel. The successful candidate will play a key role in ensuring compliance with regulatory requirements for our medical devices.Key Responsibilities:Regulatory Submissions: Prepare and submit...

  • Regulatory Affairs Specialist Medical Devices

    1 mese fa

    Milano, Lombardia, Italia Page Personnel A tempo pieno

    Regulatory Affairs Specialist Medical DevicesWe are seeking a highly motivated and detail-oriented Regulatory Affairs Specialist to join our team at Page Personnel. The successful candidate will play a key role in ensuring compliance with regulatory requirements for our medical devices.Key Responsibilities:Regulatory Submissions: Prepare and submit...

  • Regulatory Affairs Specialist Medical Devices

    2 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

    2 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...

  • Regulatory Affairs Specialist Medical Devices

    3 giorni fa

    Milano, Lombardia, Italia Page Personnel A tempo pieno

    About the RoleWe are seeking a highly motivated and detail-oriented Regulatory Affairs Specialist to support our client, a medical company that develops Class III, II, and I devices.Key ResponsibilitiesRegulatory SubmissionsPrepare and submit regulatory submissions to regulatory authorities, including 510(k) premarket notifications, Technical Files, Design...

  • Regulatory Affairs Specialist

    2 settimane fa

    Milano, Italia Hunters Group A tempo pieno

    Per azienda cliente, realtà leader nel settore farmaceutico e cosmetico in Italia, siamo alla ricerca di una figura di Regulatory Affairs Specialist - Medical Devices.Redigere e aggiornare la documentazione relativa alla legislazione e alle linee guida degli enti regolatori nazionali ed internazionali con cui ci si interfaccia; Assicurare la conformità del...

Ra Specialist Medical Devices

2 mesi fa

Milano, Italia Tn Italy A tempo pieno

col-wideJob Description:

We are seeking a highly motivated and detail-oriented Regulatory Affairs Specialist to join our team. The Regulatory Affairs Specialist will play a key role in ensuring compliance with regulatory requirements for our medical devices. This individual will collaborate cross-functionally with internal teams to support product development, registration, and post-market compliance activities.Key Responsibilities:
Prepare and submit regulatory submissions to regulatory authorities, including 510(k) premarket notifications, Technical Files, Design Dossiers, and other regulatory filings as required.
Maintain regulatory files and documentation in accordance with regulatory requirements and company procedures.
Review and interpret regulatory requirements and guidelines to ensure compliance with relevant regulations and standards, including FDA regulations (21 CFR Part 820), ISO 13485, and other applicable standards.
Support regulatory assessments for new product development projects, including regulatory strategy development, risk assessments, and regulatory impact analyses.
Monitor changes in regulations, standards, and guidance documents related to medical devices and communicate updates to relevant stakeholders.
Support post-market surveillance activities, including adverse event reporting, field corrective actions, and regulatory reporting requirements.

Master's degree in Biomedical engineering or relevant discipline.
Minimum of 3 years of experience in regulatory affairs within the medical device industry.
Experience with Class II or Class III medical devices, implantable device experience is a plus.
Knowledge of quality management systems and ISO 13485 requirements.
Strong understanding of FDA regulations, EU Medical Device Regulation (MDR), and international regulatory requirements for medical devices.
Experience preparing and submitting regulatory submissions to FDA and/or other regulatory agencies.
Excellent written and verbal communication skills, with the ability to effectively communicate complex regulatory requirements to cross-functional teams.
Detail-oriented with strong organizational skills.
Ability to work independently and collaboratively in a fast-paced environment.
Fluent in English, written and spoken.
Positive attitude during challenging situations.
Good communication skills.

Ottima opportunità di carriera.
RA Specialist Medical Devices