Lavori attuali relativi a Senior regulatory affairs specialist - Rome - Cosmo Intelligent Medical Devices
-
Senior Regulatory Affairs Consultant
4 settimane fa
Rome, Italia Planet Pharma A tempo pienoSenior Regulatory ConsultantLocation: Remote, Italy Contract Duration: 1 year Initially Company: Global Pharmaceutical Company Job Summary Provide local regulatory and technical support for assigned products, including regulatory submissions, product development documentation, and the management of project-related regulatory activities. Key...
-
Senior regulatory consultant
4 settimane fa
Rome, Italia Planet Pharma A tempo pienoTitle: UK&I Corporate Affairs AssociateCompany: Global Leading BiotechnologyLocation: Hybrid - Uxbridge/CambridgePlanet Pharma is partnered with a global leading CRO company who are currently seeking a Senior Regulatory Consultant on a predominantly remote basis. Main Responsibilities:Provide local regulatory and technical support for assigned products,...
-
Regulatory affairs api specialist
4 settimane fa
Rome, Italia PQE Group A tempo pienoSei pronto per entrare a far parte di una società di consulenza leader mondiale nell'industria farmaceutica e dei Medical Device? PQE Group è affermata in questo settore dal 1998, garantendo una presenza internazionale grazie alle 45 filiali e i 2000 dipendenti in Europa, Asia e nelle Americhe.Lavorare in una realtà di consulenza come PQE Group ti...
-
Senior regulatory affairs consultant
4 settimane fa
Rome, Italia Planet Pharma A tempo pienoSenior Regulatory ConsultantLocation: Remote, ItalyContract Duration: 1 year InitiallyCompany: Global Pharmaceutical CompanyJob SummaryProvide local regulatory and technical support for assigned products, including regulatory submissions, product development documentation, and the management of project-related regulatory activities.Key ResponsibilitiesFor...
-
Regulatory Affairs API Specialist
4 settimane fa
Rome, Italia PQE Group A tempo pienoSei pronto per entrare a far parte di una società di consulenza leader mondiale nell'industria farmaceutica e dei Medical Device? PQE Group è affermata in questo settore dal 1998, garantendo una presenza internazionale grazie alle 45 filiali e i 2000 dipendenti in Europa, Asia e nelle Americhe.Lavorare in una realtà di consulenza come PQE Group ti darà:-...
-
Senior regulatory affairs specialist
4 settimane fa
Rome, Italia Cosmo Intelligent Medical Devices A tempo pienoCosmo IMD is a division of the Cosmo Pharmaceutical group focusing on medical devices integrating artificial intelligence. Cosmo IMD has developed in recent years unrivaled expertise in multiple aspects related to the AI Med Tech business, such as medical device Hardware and Software design, healthcare Artificial Intelligence development, medical data...
-
Regulatory Affairs Officer
4 settimane fa
Rome, Italia ProductLife Group A tempo pienoIntexo, parte del Gruppo PLG, è alla ricerca di un/una Regulatory Affairs Officer con almeno due anni di esperienza nel ruolo, da inserire nella propria sede di Roma.Chi siamoIntexo Società Benefit, una realtà di consulenza del gruppo ProductLife, opera nel settore healthcare con l’obiettivo di garantire un accesso rapido, trasparente e sostenibile alle...
-
Regulatory affairs manager
4 settimane fa
Rome, Italia PQE Group A tempo pienoSei pronto per entrare a far parte di una società di consulenza leader mondiale nell'industria farmaceutica e dei Medical Device? PQE Group è affermata in questo settore dal 1998, garantendo una presenza internazionale grazie alle 45 filiali e i 2000 dipendenti in Europa, Asia e nelle Americhe.Lavorare in una realtà di consulenza come PQE Group ti...
-
Regulatory Affairs Manager
4 settimane fa
Rome, Italia PQE Group A tempo pienoSei pronto per entrare a far parte di una società di consulenza leader mondiale nell'industria farmaceutica e dei Medical Device? PQE Group è affermata in questo settore dal 1998, garantendo una presenza internazionale grazie alle 45 filiali e i 2000 dipendenti in Europa, Asia e nelle Americhe.Lavorare in una realtà di consulenza come PQE Group ti...
-
Regulatory affairs specialist junior
4 settimane fa
Rome, Italia Cosmo Intelligent Medical Devices A tempo pienoCosmo IMD is a division of the Cosmo Pharmaceutical group focusing on medical devices integrating artificial intelligence. Cosmo IMD has developed in recent years unrivaled expertise in multiple aspects related to the AI Med Tech business, such as medical device Hardware and Software design, healthcare Artificial Intelligence development, medical data...
-
Freelance Regulatory Affairs Consultant
4 settimane fa
Rome, Italia Planet Pharma A tempo pienoJob SummaryProvide regulatory and technical support for assigned products, including submissions, documentation, and project-related regulatory activities.Key Responsibilities:Stay updated on local regulatory requirements, communicating changes to stakeholders.Handle inquiries on compassionate use, early access programs, labeling exemptions, and clinical...
-
Freelance regulatory affairs consultant
4 settimane fa
Rome, Italia Planet Pharma A tempo pienoJob SummaryProvide regulatory and technical support for assigned products, including submissions, documentation, and project-related regulatory activities.Key Responsibilities:Stay updated on local regulatory requirements, communicating changes to stakeholders.Handle inquiries on compassionate use, early access programs, labeling exemptions, and clinical...
-
Freelance Regulatory Affairs Consultant
4 settimane fa
Rome, Italia Planet Pharma A tempo pienoJob SummaryProvide regulatory and technical support for assigned products, including submissions, documentation, and project-related regulatory activities. Key Responsibilities: Stay updated on local regulatory requirements, communicating changes to stakeholders. Handle inquiries on compassionate use, early access programs, labeling exemptions, and clinical...
-
Contractor regulatory manager
4 settimane fa
Rome, Italia Randstad Italia A tempo pienoRandstad Inhouse Services, specialty Pharma, is looking for a resource on behalf of Pfizer srl to join the regulatory team as CONTRACTOR REGULATORY MANAGER Type of contract : expected placement with initial fixed-term contract (12 months). Position according to the chemical collective bargaining agreement commensurate with experience. RAL 34.000€ -...
-
Packaging Development, Artwork and Serialization
1 settimana fa
Rome, Italia Dompè A tempo pienoFor our company in L'Aquila we are looking for a Packaging Development, Artworks and Serialization Specialist. ensures continuous development and improvement of the processes. Furthermore, it ensures the timely execution of serialization activities in coordination with Production department and Third Parties. - Development of new packaging ensuring...
-
Senior Villa Specialist
4 settimane fa
Rome, Italia GAP CHANGER A tempo pienoCerchiamo per Gruppo leader di Settore in Italia con un portfolio di oltre 600 ville in Itala e 300 all'estero, dei Senior Portfolio Manager (Villa Specialist), con buona esperienza nel settore short term rental di ville premium lux, che abbiano già un portfolio attivo. Ricerchiamo per diverse aree geografiche 7 professional da inserire nella...
-
Senior process engineer
4 settimane fa
Rome, Italia Bow Resources A tempo pienoJOB PURPOSEA leading energy company is seeking a Senior Process Engineer for a large-scale Carbon Capture and Storage (CCS) project. The project is advancing through the FEED, EPC, and procurement phases, and the primary objective of this role is to oversee all process and utilities engineering activities from FEED to startup.This role ensures the technical...
-
Senior Villa Specialist
3 settimane fa
Greater Rome Metropolitan Area, Italia GAP CHANGER A tempo pienoCerchiamo per EMMA VILLAS SPA - Gruppo leader di Settore in Italia con un portfolio di oltre 600 ville in Itala e 300 all'estero, dei Senior Portfolio Manager (Villa Specialist), con buona esperienza nel settore short term rental di ville premium lux, che abbiano già un portfolio attivo. Ricerchiamo per diverse aree geografiche 7 professional da inserire...
-
Product specialist
4 settimane fa
Rome, Italia Cosmo Intelligent Medical Devices A tempo pienoCosmo IMD is a division of the Cosmo Pharmaceutical group focusing on medical devices integrating artificial intelligence. Cosmo IMD has developed in recent years unrivaled expertise in multiple aspects related to the AI Med Tech business, such as medical device Hardware and Software design, healthcare Artificial Intelligence development, medical data...
-
product specialist
4 settimane fa
Rome, Italia Cosmo Intelligent Medical Devices A tempo pienoCosmo IMD is a division of the Cosmo Pharmaceutical group focusing on medical devices integrating artificial intelligence. Cosmo IMD has developed in recent years unrivaled expertise in multiple aspects related to the AI MedTech business, such as medical device Hardware and Software design, healthcare Artificial Intelligence development, medical data...
Senior regulatory affairs specialist
4 settimane fa
Cosmo IMD is a division of the Cosmo Pharmaceutical group focusing on medical devices integrating artificial intelligence. Cosmo IMD has developed in recent years unrivaled expertise in multiple aspects related to the AI Med Tech business, such as medical device Hardware and Software design, healthcare Artificial Intelligence development, medical data harvesting, clinical development, scientific production, and regulatory expertise in the US and worldwide. Cosmo IMD team is manufacturing GI Genius, the world’s first real-time artificial intelligence medical device that is globally distributed by Medtronic.About the roleMember of the Regulatory Affairs department cooperating in all aspects of the activities related to compliance with applicable regulations, jurisdictions, guidelines and standards with specific expertise and focus on vigilance and reporting requirements and periodic updates analyses.Key Responsibilities:Assess medical device safety by providing input/review to the risk management activities throughout the whole product lifecycle, health hazards evaluations, and clinical evaluation reports. Review and provide input on mitigations, labeling and training materials, adverse events, complaints, incidents, and trends.Manage and document post-marketing safety data, aggregate complaint data, individual case safety reports, literature reports with safety data, trend analysis.Manage vigilance reporting to Competent Authorities and other stakeholders according to country requirements and assess failure investigations from the regulatory viewpoint.Work with customers/users to gather information/data to support investigations and complaints management.Monitor external sources/trends on emerging issues, including complaints, MDR trends, and regulatory trends, literature and scientific publications.Transfer the regulatory compliance aspects during the design and development stage of products and act as contact point across the company functional areas.Act as department representative during audits and other regulatory body interactions in the field of vigilance and post-market surveillance.Cooperate to the management of documented material and communications with Competent Authorities, Certification Bodies, and other stakeholders according to the given regulatory aspect.Cooperate to the management of company regulatory procedures by timely awareness and implementation of changes due to the development in the regulatory landscape. Promote the culture of compliance by proactively interacting with all departments and by provision of trainings.Cooperate to the development of new activities, adapt to new challenges and opportunities, and take on new duties stemming from the development path of company activities.Qualification – Skills, and AbilitiesEducationBachelor’s degree in medicine, pharmacology, biomedical science or related scientific discipline, or equivalent. Higher degree/Ph D will be an advantage.ExperienceMinimum of 5 years of experience in the regulatory affairs field in medical device industry of which minimum of 2 years of experience in vigilance reporting according to 21 CFR Part 803 in U. S and to MDD/MDR requirements in EU.SkillsEnglish proficiency at professional levelDeep knowledge and operative understanding of Reg. (EU) 2017/745 and MDCG documents, Title 21 CFR parts 800-898, and technical standards such as ISO 13485, ISO 14971, ISO/TR 20416, ISO 62304.Practical understanding of scientific and technological aspects related to software, computer engineering, artificial intelligence, and endoscopy.Basic knowledge of Reg. (EU) 2024/1689.Personal Attributes:Strong analytical skills with a detail-oriented approach.Ability to work independently and collaboratively across multifunctional teams.Highly dynamic and adaptable to a fast-moving and innovative environment.Equal Opportunity Statement:The research complies with Legislative Decree 198/2006
