Quality Assurance Regulatory Affairs
1 giorno fa
OverviewQuality Assurance Regulatory Affairs (QARA) Specialist – Dedalus. Remote in Italy. Part of the Global Quality and Assurance Team to drive quality and regulatory excellence in healthcare technology.What you’ll achieveAs a QARA Specialist you will ensure compliance with Quality and Regulatory standards across the company, contributing to better care and safer health technologies.ResponsibilitiesParticipates in problem management teams to assure regulatory conformance by monitoring complaint creation, escalation and follow upGuide and advise managers regarding compliance issues and ensure that decisions are documented and the company is following the correct processesEnsure timely resolution of all complaints and escalated issuesProvide feedback on product problems and risk evaluation with QARA pre-market and coordinate actions with QARA ServicesCoordinate and conduct Post Market Surveillance activities, ensuring compliant regulatory reporting for applicable agencies and reporting incidents and trends within regulated timelinesPlay a leading role in addressing critical product issues and evaluating escalated complaints and problems for risksIdentify areas of improvement through analysis of product issues, quality metrics, internal audits and customer complaintsReport on Post Market activities during Management Review meetings (site, divisional and healthcare levels)Provide senior-level contributions to develop the QARA department into a professional, proactive and competent teamQualificationsFamiliar with international regulations and standards pertaining to medical devices development and deployment; familiarity with ISO 9001, ISO 13485, ISO 14971 and ability to interpret and work with regulations and standardsExposure to risk management processesKnowledge of software development methodologies and practicesStrong problem solving and project management skillsExcellent communication (verbal and written), research, organizational and interpersonal skillsDatabase and software tool manipulation skillsKnowledge of statistical techniques and data analysisVery good English skills both verbal and writtenUniversity degree in Engineering, Computer Science or ScienceDedalus is a leading healthcare technology company dedicated to helping clinicians and nurses deliver better care. We are committed to diversity and inclusion and to creating a respectful, inclusive culture across our global workforce.Location: Italy (remote)Employment type: Full-time#J-18808-Ljbffr
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Quality Assurance
2 settimane fa
Bologna, Italia Dedalus SA A tempo pienoVous souhaiter donner du sens à votre métier ? Vous voulez contribuer à l'amélioration de nos soins de santé ? Alors rejoignez notre équipe! We are currently looking for a Quality Assurance & Regulatory Affairs Specialist (M/F/d). He/she will provide guidance and execute regulatory plans and strategies, working with the project core team. He/she...
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Quality Assurance Regulatory Affairs
5 giorni fa
bologna, Italia Dedalus A tempo pienoOverviewQuality Assurance Regulatory Affairs (QARA) Specialist – Dedalus. Remote in Italy. Part of the Global Quality and Assurance Team to drive quality and regulatory excellence in healthcare technology.What you’ll achieveAs a QARA Specialist you will ensure compliance with Quality and Regulatory standards across the company, contributing to better...
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Quality Assurance
2 settimane fa
Bologna, Italia Dedalus Italia S.p.A. A tempo pienoAbout Dedalus We are a Global European Health Software Company and one of the largest in the world’s largest. Our shareholding structure guarantees financial capacity and stability, thanks to the investment from Ardian, the largest private investment company in Europe and the fourth largest in the world. In 2016, Dedalus decided to accelerate its...
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Quality Assurance
1 settimana fa
Bologna, Italia Dedalus Italia S.p.A. A tempo pienoAbout Dedalus We are a Global European Health Software Company and one of the largest in the world’s largest. Our shareholding structure guarantees financial capacity and stability, thanks to the investment from Ardian, the largest private investment company in Europe and the fourth largest in the world. In 2016, Dedalus decided to accelerate its...
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Quality Assurance
1 settimana fa
Bologna, Italia Dedalus Italia S.p.A. A tempo pienoAbout Dedalus We are a Global European Health Software Company and one of the largest in the world’s largest. Our shareholding structure guarantees financial capacity and stability, thanks to the investment from Ardian, the largest private investment company in Europe and the fourth largest in the world. In 2016, Dedalus decided to accelerate its...
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Quality and Regulatory Specialist
3 giorni fa
Bologna, Italia NonStop Consulting A tempo pieno**Contratto**:**CCNL Commercio, tempo indeterminato, full-time **Esperienza richiesta**:**minimo 4-5 anni in ambito medicale **Settore**:**Medicale, dispositivi medici attivi Cerchiamo un **Quality & Regulatory Affairs Specialist** che farà parte del team Regolatorio e Qualità, coordinando attività interne ed esterne e supportando la conformità...
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Regulatory Affairs
5 giorni fa
Bologna, Italia Page Personnel Italia A tempo pienoCertificazioni internazionali e supporto alla clientela per assicurare la compliance regolatoria del prodotto in relazione al mercato di riferimento (principalmente USA-FDA ed Europa-MDR); - Gestione iter di approvazione da parte di FDA, enti notificati e agenzie governative; - Partecipazione all'analisi dei rischi, piano di verifica e...
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PMO Sr. Manager, Quality, Regulatory
3 settimane fa
Bologna, Italia Alfasigma S.p.A. A tempo pienoSelect how often (in days) to receive an alert: PMO Sr. Manager, Quality, Regulatory & Safety Purpose of the Job The Project Manager, Regulatory, Safety & Quality will act as a strategic partner and operational right hand to the Head of Regulatory, Safety & Quality, enabling the effective execution of priorities across the function.The role will coordinate...
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PMO Sr. Manager, Quality, Regulatory
2 settimane fa
bologna, Italia Alfasigma S.p.A. A tempo pienoSelect how often (in days) to receive an alert:PMO Sr. Manager, Quality, Regulatory & SafetyPurpose of the JobThe Project Manager, Regulatory, Safety & Quality will act as a strategic partner and operational right hand to the Head of Regulatory, Safety & Quality, enabling the effective execution of priorities across the function.The role will coordinate...
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Non-Pharma Global Regulatory Affairs Specialist
5 giorni fa
bologna, Italia Alfasigma S.p.A. A tempo pienoNon-Pharma Global Regulatory Affairs SpecialistAlfasigma is a privately held global healthcare company founded over 75 years ago in Italy, where it remains headquartered today in Bologna and Milan. The Group operates in over 100 markets spanning Europe, North and South America, Asia, and Africa.Over three years ago, we embarked on a transformative journey to...
