Regulatory Affairs Specialist for Medical Devices

1 mese fa


Milano, Lombardia, Italia Page Personnel A tempo pieno

Ottima opportunità di carriera presso Page Personnel

Il nostro cliente è una società medica che sviluppa dispositivi medici di classe III, II e I. Ci stiamo cercando un Regolatore Affari con esperienza nel settore dei dispositivi medici.

Responsabilità chiave:

  • Preparare e inviare invii regolatori alle autorità regolatorie, tra cui le notifiche di premarket 510(k), i file tecnici, i dossier di progetto e altri invii regolatori richiesti.
  • Mantenersi aggiornato sulle normative regolatorie e sui procedimenti interni della società.
  • Supportare le attività di post-vendita per i dispositivi medici, incluso il monitoraggio degli eventi avversi, le azioni correttive sul campo e le richieste di rapporto regolatorio.

Requisiti:

  • Laurea magistrale in ingegneria biomedicalica o disciplina affine.
  • Almeno 3 anni di esperienza nel settore delle affari regolatori.
  • Conoscenza dei sistemi di gestione della qualità e delle normative ISO 13485.
  • Capacità di comunicare efficacemente con i team interfunzionali.


  • Milano, Lombardia, Italia Page Personnel A tempo pieno

    Page Personnel is seeking a highly skilled Regulatory Affairs Specialist to play a key role in ensuring compliance with regulatory requirements for our medical devices. The ideal candidate will have a strong understanding of FDA regulations, EU Medical Device Regulation (MDR), and international regulatory requirements for medical devices.About the RoleWe are...


  • Milano, Lombardia, Italia Cpl Healthcare A tempo pieno

    Job Title: Associate Director, Regulatory Affairs Medical Device Lifecycle ManagementJob Type: Full Time, Permanent PositionLocation: HybridRemuneration: Attractive salary and packageAbout the Role:We are seeking a highly experienced Associate Director, Regulatory Affairs Medical Device Lifecycle Management to join our team. As a key member of our Regulatory...


  • 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.


  • Milano, Lombardia, Italia Cpl Healthcare A tempo pieno

    Job Title: Associate Director, Regulatory Affairs - Medical Device/Post Market SurveillanceAbout the Role:As a key member of our Regulatory Affairs team, you will be responsible for the strategic lifecycle management of our Medical Devices. This includes oversight of all activities required for the successful and smooth integration of new products following...


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

    Job Description: We are seeking a highly skilled Regulatory Affairs Manager to join our team at W Executive S.R.L. The successful candidate will be responsible for ensuring that all our products meet the relevant government legislation and regulations, while prioritizing patient safety and efficacy. The main responsibilities of this role include:Managing the...


  • 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....


  • 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...


  • Milano, Lombardia, Italia The Kraft Heinz Company A tempo pieno

    Job DescriptionWe are seeking a highly skilled Regulatory Affairs Manager to join our team in Milan. As an expert in regulatory affairs, you will play a crucial role in ensuring compliance with food legislation and government guidelines.About the RoleYou will be responsible for reviewing and approving label artwork to ensure it meets legislative...


  • Milano, Lombardia, Italia Healthcare Businesswomen'S Association A tempo pieno

    Healthcare Businesswomen'S Association is a leader in the Generic and Biosimilar medicines sector, touching the lives of almost 500 million patients annually. We're now seeking a skilled Regulatory Affairs Specialist to join our team and play a crucial role in shaping the future of our organization.**Job Summary:**We are looking for an experienced Regulatory...


  • Milano, Lombardia, Italia Pfizer A tempo pieno

    Pfizer is seeking a highly skilled Regulatory Affairs Specialist to join our team in the Early Phase, Oncology department. This role will provide strategic expertise and leadership in EU regulatory strategies for designated early-stage oncology portfolio projects/products.**Job Summary:**The successful candidate will be responsible for representing Pfizer's...


  • Milano, Lombardia, Italia Pfizer A tempo pieno

    Job OverviewWe are seeking a skilled Regulatory Affairs Specialist to join our team in the early-phase oncology portfolio. This role will play a crucial part in ensuring regulatory compliance and advancing the development of new cancer treatments.


  • Milano, Lombardia, Italia Livanova Plc A tempo pieno

    Marketing Communications Specialist for Medical DevicesAt LivaNova Plc, we are seeking a talented Marketing Communications Specialist to support our Global Strategic Marketing team. In this role, you will be responsible for assisting with the development and implementation of marketing communications strategies for our Cardiopulmonary division.Key...


  • Milano, Lombardia, Italia Pfizer A tempo pieno

    Job DescriptionAt Pfizer, we are committed to transforming patients' lives through breakthroughs in drug discovery and development.As a Europe Regulatory Affairs Specialist, you will play a critical role in leading and implementing EU regulatory strategies in agreement with key stakeholders. Your expertise will ensure timely submissions and approvals, while...


  • Milano, Lombardia, Italia Randstad Italia A tempo pieno

    Regulatory Operations SpecialistRandstad Inhouse Services, a leading pharmaceutical company, is seeking a highly skilled Regulatory Operations Specialist to join their team. The ideal candidate will be responsible for managing regulatory change management, renewal, and query activities for products manufactured by External Supply Quality (ESQ) managed...


  • Milano, Lombardia, Italia Abbott A tempo pieno

    As a Technical Support Specialist for Electrophysiology Devices at Abbott, you will play a crucial role in promoting our product lines through professional and technical support to medical and sales personnel. Your primary function will be to attend electrophysiology procedures and address any issues related to the utilization of EP devices.


  • Milano, Lombardia, Italia Randstad A tempo pieno

    Randstad Inhouse Services is partnering with Pfizer to find a Regulatory Operations Specialist to support their specialty Pharma team. The ideal candidate will be responsible for managing regulatory change activities, reviewing and approving changes, and providing support for the closure of deficiency letters and regulatory requests.Key...


  • Milano, Lombardia, Italia Randstad Italia spa A tempo pieno

    Ricerche per un Regulatory Operations Specialist presso Randstad Italia spa.Descrizione del lavoroLa nostra azienda, Randstad Italia spa, è alla ricerca di un Regulatory Operations Specialist per sostenere il nostro team di Regulatory Affairs.Il candidato ideale dovrà essere in grado di assicurare la gestione dei cambiamenti regolatori, comprese le...


  • Milano, Lombardia, Italia Farfetch A tempo pieno

    Role OverviewNew Guards Group is a leading luxury fashion company that seeks a skilled Compliance Regulatory Specialist to contribute to the regulatory compliance and quality assurance of our eyewear products worldwide.About the RoleAs a Compliance Regulatory Specialist, you will be responsible for interpreting and applying worldwide regulatory requirements,...


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

    About the RoleThis is a remote opportunity to develop and maintain peer-to-peer relationships with key medical experts, supporting trial enrollment, program protocol training, and ensuring healthcare professionals have the latest information on clinical development programs.Key ResponsibilitiesDevelop and maintain collaborations with medical experts,...


  • Milano, Lombardia, Italia Pfizer, S.A. de C.V A tempo pieno

    Senior Associate, Early Phase, Regulatory AffairsWe're in relentless pursuit of breakthroughs that change patients' lives. We innovate every day to make the world a healthier place.To fully realize our purpose – Breakthroughs that change patients' lives – we have established clear expectations regarding what we need to achieve for patients and how we...