Regulatory & Scientific Affairs Specialist
4 settimane fa
Regulatory & Scientific Affairs SpecialistWe are looking for a Regulatory & Scientific Affairs Specialist to join our team in Italia (Piombino Dese) . The chosen candidate will be responsible for or performing the regulatory intelligence process and regulatory and standard assessments, arranging registration dossier of medical devices, drug device combinations and drug container systems as well as participating in the dossier submission to the International Regulatory Agencies.Key ResponsibilitiesExecutes the approved Regulatory Affairs strategy plan, providing the manager above with feedback and insights aimed at addressing the decision-making process and implementing continuous improvements actions and initiatives.Participates in monitoring the regulatory requirements, assesses the relevant risks and impacts, and list the applicable regulatory standards that the functions involved translates into procedures.Prepares required documents (such as: LoA, Technical documents and declarations) for the approval of the manager above and for response to relevant stakeholders such as Regulatory Agencies, Bodies, Health Authorities.Maintains timely, accurate, exhaustive and UpToDate all regulatory files, ensuring the accuracy and alignment with applicable standards, norms and regulatory requirements, applying guidelines, procedures and approach to functions involved.Collaborate with Compliance team on reviewing procedures, work instructions, and other relevant documents, ensuring the alignment of all SG plants and their compliance with Quality Management System and applicable standards.Monitors and assesses impact of relevant global regulations, guidelines, and current regulatory environment by collecting information retrieved from scientific journals, institutional and academic websites, guidelines, databases and from the participation of seminars and symposiums.Participates, collaborating with the team and the manager above services in the audit sessions as well as during the customers technical meetings, defining appropriate CAPA plan, working closely with the involved teams, able at solving the relevant findings, ensuring sustainable and long-term efficacy and efficiency at both processes and systems level.Qualifications2-5 years of experience within quality healthcare (Pharmaceutical, Medical Device, Pharmaceutical Packaging) industriesTechnical Master DegreeKnowledge of Regulatory, Legal and standard requirements applicableKnowledge of applicable standards such as ISO, cGMPs, FDA, Medical Device Regulations etc. (such as ISO 13485, 14971, MDR etc.)Knowledge of Risk Management: methodologies, techniques, tools and applications (i.e FMEA, control strategy)Knowledge of Quality Management System: process, features techniquesProject Management: methodologies, techniques, tools and applicationsAbout UsWe are a dynamic organization with great customers and a culture where people are valued and empowered to deliver amazing results. We are also growing and looking to hire talented and passionate individuals to join our teamReferrals increase your chances of interviewing at Stevanato Group by 2xGet notified about new Regulatory Specialist jobs in Piombino Dese, Veneto, Italy .Seniority LevelAssociateEmployment TypeFull-timeJob FunctionProduction and Quality AssuranceIndustriesPharmaceutical Manufacturing#J-18808-Ljbffr
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Regulatory & Scientific Affairs Specialist
2 settimane fa
Piombino Dese, Veneto, Italia Stevanato Group A tempo pieno 40.000 € - 80.000 € all'anoWe are looking for aRegulatory & Scientific Affairs Specialistto join our team inItalia (Piombino Dese). The chosen candidate will be responsible for or performing the regulatory intelligence process and regulatory and standard assessments, arranging registration dossier of medical devices, drug device combinations and drug container systems as well as...
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QA Specialist – Process Excellence
2 settimane fa
Piombino Dese, Italia Stevanato Group A tempo pienoUn'azienda nel settore farmaceutico, con sede a Piombino Dese, cerca un Quality Assurance Specialist. Il candidato ideale avrà una laurea scientifica e sarà responsabile dell'analisi e gestione delle deviazioni di processo, coordinando progetti di miglioramento e analizzando dati attraverso strumenti statistici. Offriamo un ambiente di lavoro stimolante e...
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QA Specialist – Process Excellence
2 settimane fa
Piombino Dese, Italia Stevanato Group A tempo pienoUn'azienda nel settore farmaceutico, con sede a Piombino Dese, cerca un Quality Assurance Specialist. Il candidato ideale avrà una laurea scientifica e sarà responsabile dell'analisi e gestione delle deviazioni di processo, coordinando progetti di miglioramento e analizzando dati attraverso strumenti statistici. Offriamo un ambiente di lavoro stimolante e...
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Quality Assurance Specialist | Process
7 giorni fa
Piombino Dese, Italia Altro A tempo pienoUn'azienda nel settore quality assurance ricerca un Quality Assurance Specialist per il proprio Head Quarter a Piombino Dese. La figura selezionata dovrà garantire la qualità del prodotto interfacciandosi con produzione e diverse funzioni aziendali. Tra le attività principali ci sono l'analisi delle deviazioni di processo, la gestione di progetti di...
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Quality Assurance Specialist | Process
1 settimana fa
Piombino Dese, Italia Experteer Italy A tempo pienoUn'azienda nel settore quality assurance ricerca un Quality Assurance Specialist per il proprio Head Quarter a Piombino Dese. La figura selezionata dovrà garantire la qualità del prodotto interfacciandosi con produzione e diverse funzioni aziendali. Tra le attività principali ci sono l'analisi delle deviazioni di processo, la gestione di progetti di...
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Validation Specialist
2 giorni fa
Piombino Dese, Italia Stevanato Group A tempo pienoWe are looking for a **Validation Specialist** to join the Quality Validation team based in Piombino Dese (PD). The function ensures the approval and validation of all production processes and supporting IT systems, as well as utilities, test methods, equipment and cleaning processes, producing a product that meets all applicable internal and regulatory...
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QA Specialist Piombino Dese
1 settimana fa
Piombino Dese, Italia Experteer Italy A tempo pienoLaurea ad indirizzo scientifico Esperienza preferibilmente all'interno di realtà strutturate Buona conoscenza della lingua inglese; Ottime doti relazionali: Capacità di lavorare in team; Precisione e flessibilità; Per il nostro Head Quater situato a Piombino Dese stiamo ricercando la figura di Quality Assurance Specialist. La persona, inserita all'interno...
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Validation Specialist
4 settimane fa
Piombino Dese, Italia Altro A tempo pienoGet AI-powered advice on this job and more exclusive features.We are looking for a Validation Specialist – Quality to join our HQ team in Piombino Dese (Padova) . The chosen candidate will be responsible to execute the qualification and validation processes assigned, maintain up-to-date tools, guidelines, and other procedures aimed at achieving reliability...
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Validation Specialist
4 settimane fa
Piombino Dese, Italia Altro A tempo pienoGet AI-powered advice on this job and more exclusive features.We are looking for aValidation Specialist – Qualityto join our HQ team inPiombino Dese (Padova) . The chosen candidate will be responsible to execute the qualification and validation processes assigned, maintain up-to-date tools, guidelines, and other procedures aimed at achieving reliability...
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Quality Compliance Specialist
1 settimana fa
Piombino Dese, Italia Stevanato Group A tempo pienoWe are looking for _Quality compliance specialist_ to be insert in our quality compliance department in** Piombino Dese** (PD) directly reporting to** **Quality Compliance Manager. **Management system compliance execution** - Contributes to implement and maintain UpToDate the relevant management system, ensuring the compliance with the applicable...
