Lead Vigilance and QARA Spain
hace 6 días
Insulet started in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod® product platform. In the last two decades we have improved the lives of hundreds of thousands of patients by using innovative technology that is wearable, waterproof, and lifestyle accommodating. We are looking for highly motivated, performance driven individuals to be a part of our expanding team. We do this by hiring amazing people guided by shared values who exceed customer expectations. Our continued success depends on it Position Overview Review, analyze, and compose responses to regulatory agencies regarding medical device reportable events and collaborate both within post market surveillance and across other functions, including customer care, quality, clinical and regulatory to help ensure compliance with reporting requirements and good documentation practices. This position reports to the Director EMEA Vigilance and QARA Responsibilities Act as the local vigilance contact with the Spanish competent authority Act as the representative for the regions under their responsibility Support activities for global vigilance reporting such as Process, prepare, write and submit RFAI requests from Competent Authorities Maintain the Vigilance Mailbox and monitor emails Support cases reportability assessment when needed by completing due diligence on additional information requests with the complaint reporter Critically interpret results of trending reports, failure investigations/engineering reports and determines how to present the data most effectively in a succinct manner Attend/support meetings with the competent authorities Liaise with external partners (ex. Distributors) regarding vigilance and quality matters Process due diligence requests Process investigation results requests Collaborate with other functions to compile compliance documentation for post market Follow processes and operational policies in selecting methods and techniques for obtaining solutions Support regional markets with activities related to product being introduced or currently on the market Provide support as needed for internal and external audits/inspections Complete administrative verification on product to be distributed on the EU markets as needed Act as local Regulatory point of contact in Spain Complete regulatory review and validation of material intended for use with third parties in Spain Education and Experience Minimum Requirements: Relevant experience in professional writing in a medical technology, life sciences, or healthcare setting Complaint processing experience Knowledge of the EU MDR 745/2017 and country specific vigilance related regulations BA/BS degree Effective verbal and technical writing skills. Ability to communicate at multiple levels of an organization. Ability to organize and judge priorities Ability to assimilate and interpret scientific content, and translate information for appropriate audience in a succinct manner Strong attention to detail with excellent grammatical, editorial, and proofreading skills Spanish native speaking person, must be fluent in speaking and writing in English Preferred Skills and Competencies Willingness to pursue additional learning and build qualifications in professional field, as required. Experience leading/managing improvement projects. #LI-KJ1 #LI-Hybrid #J-18808-Ljbffr
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Lead Vigilance and QARA Spain
hace 2 días
Madrid, España Insulet Corporation A tiempo completoLead Vigilance and QARA Spain page is loaded## Lead Vigilance and QARA Spainlocations: ES - Spain: ES - Spain (Office): Madrid, Spaintime type: Full timeposted on: Posted Todayjob requisition id: REQ-2025-13466Insulet started in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom and healthier lives through the...
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Lead Vigilance and QARA Spain
hace 1 hora
Madrid, España Insulet Corporation A tiempo completoLead Vigilance and QARA Spain page is loaded## Lead Vigilance and QARA Spainlocations: ES - Spain: ES - Spain (Office): Madrid, Spaintime type: Full timeposted on: Posted Todayjob requisition id: REQ- Insulet started in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod...
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Lead Vigilance and QARA Spain
hace 1 semana
Madrid, España Insulet Corporation A tiempo completoLead Vigilance and QARA Spain page is loaded## Lead Vigilance and QARA Spainlocations:Se pueden requerir diversas habilidades interpersonales y experiencia para el siguiente puesto. Por favor, asegúrese de consultar la descripción a continuación con atención.ES - Spain:ES - Spain (Office):Madrid, Spaintime type:Full timeposted on:Posted Todayjob...
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Spain Vigilance
hace 2 semanas
madrid, España Insulet Corporation A tiempo completoA global medical technology company is seeking a Lead Vigilance and QARA professional in Madrid, Spain. The role involves ensuring regulatory compliance with medical devices, acting as the local contact for vigilance matters, and supporting global reporting activities. Candidates should have a BA/BS degree, experience in complaint processing, and fluency in...
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Spain Vigilance
hace 8 horas
Madrid, España Insulet Corporation A tiempo completoA global medical technology company is seeking a Lead Vigilance and QARA professional in Madrid, Spain. The role involves ensuring regulatory compliance with medical devices, acting as the local contact for vigilance matters, and supporting global reporting activities. Candidates should have a BA/BS degree, experience in complaint processing, and fluency in...
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Spain Vigilance
hace 1 semana
Madrid, España Insulet Corporation A tiempo completoA global medical technology company is seeking a Lead Vigilance and QARA professional in Madrid, Spain.Por favor, asegúrese de leer atentamente los siguientes detalles antes de enviar cualquier solicitud.The role involves ensuring regulatory compliance with medical devices, acting as the local contact for vigilance matters, and supporting global reporting...
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Lead Vigilance and QARA Spain
hace 6 días
Madrid, España Insulet Corporation A tiempo completoInsulet started in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod® product platform. In the last two decades we have improved the lives of hundreds of thousands of patients by using innovative technology that is wearable, waterproof, and lifestyle accommodating. We are...
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Lead Vigilance and QARA Spain
hace 6 días
Madrid, España Insulet A tiempo completoInsulet started in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod® product platform. In the last two decades we have improved the lives of hundreds of thousands of patients by using innovative technology that is wearable, waterproof, and lifestyle accommodating.We are...
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Lead Vigilance and QARA Spain
hace 1 semana
Madrid, España Insulet Corporation A tiempo completoInsulet started in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod® product platform. In the last two decades we have improved the lives of hundreds of thousands of patients by using innovative technology that is wearable, waterproof, and lifestyle accommodating.¿Todo...
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Lead Vigilance and QARA Spain
hace 1 semana
Madrid, España Insulet Corporation A tiempo completoInsulet started in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod® product platform. In the last two decades we have improved the lives of hundreds of thousands of patients by using innovative technology that is wearable, waterproof, and lifestyle accommodating.Los...
