Junior Regulatory Product Maintenance specialist
Salva questo lavoro e mantieni la tua ricerca organizzata
Crea un account gratuito per salvare lavori, creare avvisi e tornare a questa inserzione dalla tua dashboard.
Continuando accetti i nostri Termini & Informativa sulla privacy.
Why Orthofix?
Guided by our organizational values – Take Ownership | Innovate Boldly | Win Together – we collaborate closely with world-class surgeons and other partners to improve people’s quality of life. At Orthofix, we want team members who build relationships and share knowledge, challenge the status quo, and deliver results every day to help us achieve our vision to be the unrivaled partner in Med Tech. Our global team of over 1,600 employees brings to market highly innovative, cost-effective, and user-friendly medical technologies that heal musculoskeletal pathologies for patients and the healthcare professionals who treat them. Looking to change people’s lives? Look no further. We are looking for a Junior Regulatory Product Maintenance specialist to join our Regulatory Affairs team, based in Bussolengo (Verona) on a temporary contract of 1 year. You will report to the Regulatory Affairs Manager. You will be collaborate with Regulatory Technical Product and RA Administrative specialists to assure that the Product Technical documentation Files and related documentation are up to date in compliance to the international regulatory requirements in time with deadline. Responsibilities include collaboration with all internal departments, consultants, subsidiaries, distributors, external laboratories and suppliers for successful regulatory activities in each impacted area. What will your contribution be?- Assures, that the Regulatory Technical documentation on paper or on electronic relevant to a new or modified products is adequately updated and archived in the proper Technical File (DMF) and indexes are up to date.
- Maintain UpToDate Regulatory EU Product Technical Files and FDA Product Applications File in collaboration with departments, complete and accurate and available for regulatory Product(s) Applications International submission on time to the planned deadline, as indicated by Regulatory Affairs manager and/or RA team.
- Prepare and maintain updated Procedure Pack Files.
- As needed, support the Regulatory team in the daily regulatory activities, as indicated by the Regulatory manager
- Prepare and maintain UpToDate Product technical sheet in Italian and English version
- Interface with Notified body for the update of the Technical Documentation Files maintenance
- Supporting the International registrations documentation’ requests
- Supporting for the Products leaflets/IFU and labeling maintenance
- Collaborate for any changes to Product impacting the regulatory documents
- Travel 10%
- Technical degree
- 1 years in similar position preferably in a Medical Device Company
- Good English and Italian, both written and oral
- Knowledge of medical device European MDR. Any additional regulations knowledge, such as U.S. Japanese, Canadian, Latin America, Middle East, India,Asia-Pacific regulations, would be a plus.
- Technical knowledge of the medical devices and of the Company manufacturing processes
- Excellent organizational skills and multitasking
- Problem solving
- Work precisely according to procedures, rules and regulations
- Result oriented
- Skill as autonomy, orderliness, attention to detail and deadline
- Analytical approach to regulatory issues
- Project management
- Responsibility for the assigned tasks
- Able to work in team and autonomously as well
- Open mind to different culture
- Able to work under pressure
- Able to work on assigned multitasks
- Friendly, warm, and innovative atmosphere
- Healthy, inspiring, and international and inclusive work environment
- Training and development opportunities
- Competitive reward packages
- Social and company events
- Wellbeing in
-
Verona, Veneto, Italia Orthofix Holdings, Inc. Tempo pieno## Junior Regulatory Product Maintenance specialistApply: VeronaL'esperienza richiesta ai candidati, così come le competenze e le qualifiche aggiuntive necessarie per questo lavoro, sono elencate di seguito.- Bussolengo: Full time: Posted Yesterday: OFX26331**Why Orthofix?**Guided by our organizational values – **Take Ownership** | **Innovate Boldly** |...
-
Junior Regulatory Product Maintenance specialist
3 giorni fa
Verona, Veneto, Italia Medicina Tempo pieno## Junior Regulatory Product Maintenance specialistApply: Verona - Bussolengo: Full time: Posted Yesterday: OFX26331**Why Orthofix?**Guided by our organizational values – **Take Ownership** | **Innovate Boldly** | **Win Together** – we collaborate closely with world-class surgeons and other partners to improve people's quality of life. At Orthofix, we...
-
Junior Regulatory Product Specialist
19 ore fa
Verona, Veneto, Italia Orthofix Holdings, Inc. Tempo pieno 30.000 € - 35.000 € ContrattoOrthofix Holdings, Inc.Faccia ora il prossimo passo nella sua carriera: scorra verso il basso per leggere la descrizione completa del ruolo e invii la sua candidatura.in Bussolengo (Verona) seeks a Junior Regulatory Product Maintenance specialist on a 1-year temporary contract.You will ensure regulatory documentation is up to date, maintain EU Product...
-
Junior Regulatory Product Specialist
3 giorni fa
Verona, Veneto, Italia Medicina Tempo pienoOrthofix Holdings, Inc. in Bussolengo (Verona) seeks a Junior Regulatory Product Maintenance specialist on a 1-year temporary contract.You will ensure regulatory documentation is up to date, maintain EU Product Technical Files, and support regulatory submissions in a global framework. You will collaborate with Regulatory Technical Product and RA...
-
Junior AI
6 giorni fa
Verona, Veneto, Italia Sysdig Tempo pienoOverview As a Support Engineer at Sysdig, you will help clinicians and teams learn to use cloud security tools effectively, building hands-on lab content and delivering engaging training. You’ll automate parts of the training setup, troubleshoot the delivery platform, and co-create sessions with senior instructors. Your work will blend practical...
-
Quality Assurance Regulatory Affairs
3 ore fa
Verona, Veneto, Italia Dedalus 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.Scopra esattamente quali competenze, esperienze e qualifiche sono necessarie per avere successo in questo ruolo prima di candidarsi.What you’ll...
-
Technical Product RA Specialist
16 ore fa
Verona, Veneto, Italia Orthofix Holdings, Inc. Tempo pienoWhy Orthofix?Guided by our organizational values – Take Ownership | Innovate Boldly | Win Together – we collaborate closely with world-class surgeons and other partners to improve people’s quality of life. At Orthofix, we want team members who build relationships and share knowledge, challenge the status quo, and deliver results every day to help us...
-
Product Compliance
19 ore fa
Verona, Veneto, Italia Xylem Tempo pienoXylem is a Fortune 500 global water solutions company dedicated to advancing sustainable impact and empowering the people who make water work every day. As a leading water technology company with 23,000 employees operating in over 150 countries, Xylem is at the forefront of addressing the world's most critical water challenges. We invite passionate...
-
Verona, Veneto, Italia Orthofix Holdings, Inc. Tempo pienoOrthofix Holdings, Inc.Tutti i candidati sono invitati a leggere attentamente la seguente descrizione del lavoro e le relative informazioni prima di candidarsi.in Bussolengo (Verona) is seeking a Technical Product Regulatory Affairs Specialist to join our Regulatory Affairs team as a maternity substitution.You will ensure availability of Technical...
-
Global Product Compliance
3 ore fa
Verona, Veneto, Italia Xylem Tempo pienoXylem, a Fortune 500 global water solutions company, is seeking a Product Compliance & Certification Specialist to ensure products meet safety, regulatory, and certification requirements across markets. The role collaborates with Product Management, Engineering, Manufacturing, Sourcing, customers, and certification bodies throughout the product lifecycle.You...