Lead Vigilance and QARA Spain
hace 3 días
Position OverviewReview, 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.ResponsibilitiesAct as the local vigilance contact with the Spanish competent authorityAct as the representative for the regions under their responsibilitySupport activities for global vigilance reporting such as Process, prepare, write and submit RFAI requests from Competent AuthoritiesMaintain the Vigilance Mailbox and monitor emailsSupport cases reportability assessment when needed by completing due diligence on additional information requests with the complaint reporterCritically interpret results of trending reports, failure investigations/engineering reports and determine how to present the data most effectively in a succinct mannerAttend/support meetings with the competent authoritiesLiaise with external partners (ex. Distributors) regarding vigilance and quality mattersProcess due diligence requestsProcess investigation results requestsCollaborate with other functions to compile compliance documentation for post marketFollow processes and operational policies in selecting methods and techniques for obtaining solutionsSupport regional markets with activities related to product being introduced or currently on the marketProvide support as needed for internal and external audits/inspectionsComplete administrative verification on product to be distributed on the EU markets as neededAct as local Regulatory point of contact in SpainComplete regulatory review and validation of material intended for use with third parties in SpainEducation And ExperienceRelevant experience in professional writing in a medical technology, life sciences, or healthcare settingComplaint processing experienceKnowledge of the EU MDR 745/2017 and country specific vigilance related regulationsBA/BS degreeEffective verbal and technical writing skills. Ability to communicate at multiple levels of an organizationAbility to organize and judge prioritiesAbility to assimilate and interpret scientific content, and translate information for appropriate audience in a succinct mannerStrong attention to detail with excellent grammatical, editorial, and proofreading skillsSpanish native speaking person, must be fluent in speaking and writing in EnglishPreferred Skills And CompetenciesWillingness to pursue additional learning and build qualifications in professional field, as requiredExperience leading/managing improvement projects #J-18808-Ljbffr
-
Lead Vigilance
hace 3 días
Ourense, España Insulet Corporation A tiempo completoA healthcare technology company based in Galicia, Spain is seeking a Regulatory Affairs Specialist to ensure compliance with medical device reporting requirements. Responsibilities include serving as the local contact with Spanish authorities, managing vigilance processes, and supporting audits. Candidates should have relevant experience in medical writing...
-
Engineering Lead, Cloud-Scale Catastrophe Modeling
hace 1 semana
Ourense, España KatRisk A tiempo completoA catastrophe risk modeling company based in Ourense, Spain, is seeking a hands-on Engineering Leader with deep C++ expertise to oversee and transform their catastrophe risk assessment platform into a scalable, cloud-native solution. The ideal candidate will lead a talented team, optimizing performance and reliability while collaborating with Data Science...
-
Engineering Lead, Cloud-Scale Catastrophe Modeling
hace 2 semanas
Ourense, España KatRisk A tiempo completoA catastrophe risk modeling company based in Ourense, Spain, is seeking a hands-on Engineering Leader with deep C++ expertise to oversee and transform their catastrophe risk assessment platform into a scalable, cloud-native solution. The ideal candidate will lead a talented team, optimizing performance and reliability while collaborating with Data Science...
-
Back Office Spain, Uk And Nordics Countries
hace 2 semanas
Ourense, Orense, España Estaños y Soldaduras Senra SLU A tiempo completoBack office Spain, UK and Nordics countriesAtSenra Estaños y Soldaduras, a leading company in the manufacturing and distribution of tin and soldering solutions, we are looking for aBack Office Specialistto join our team and support our commercial and administrative operations.Key ResponsibilitiesAdministrative and operational support to the sales teamOrder...
-
Engineering Lead
hace 2 semanas
Ourense, España KatRisk A tiempo completoABOUT KATRISKKatRisk is a leading provider of catastrophe risk modeling solutions, dedicated to helping businesses and organizations understand, manage, and mitigate the risks associated with natural disasters. Our innovative technology and expertise enable clients to make informed decisions, optimize their risk management strategies, and safeguard their...
-
Sales and client support advisor
hace 3 días
Ourense, España Exactly.es A tiempo completoSales and client support | €1750-2000 gross salary | Private healthcare included¿Es este el puesto que está buscando? Si es así, siga leyendo para obtener más detalles y no olvide enviar su solicitud hoy mismo.Exactly Accountancy is an international accountancy firm based in Altea. We help expats and entrepreneurs in Spain with everything from tax and...
-
Engineering Lead
hace 3 días
Ourense, España KatRisk A tiempo completoABOUT KATRISK KatRisk is a leading provider of catastrophe risk modeling solutions, dedicated to helping businesses and organizations understand, manage, and mitigate the risks associated with natural disasters. Our innovative technology and expertise enable clients to make informed decisions, optimize their risk management strategies, and safeguard their...
-
Platform Lead
hace 4 semanas
Ourense, España Xebia A tiempo completoAbout Xebia With over 20 years of experience, our global network of passionate technologists and pioneering craftsmen deliver cutting-edge technology and game-changing consulting to companies on the brink of transformation. Since 2001, we have grown from a Java company into a full-service digital consulting company with 5,500+ professionals working on a...
-
Analytics Lead
hace 2 semanas
Ourense, España Liquid Barcodes A tiempo completoThe Role We are seeking a highly skilled and experienced Analytics Lead to join our technology and product teams in Málaga. In this role, you will take a leading part in defining the company’s analytics strategy, building frameworks for measuring product and customer performance, and providing actionable insights that drive business growth. This is a...
-
Lead Field Service Technician
hace 4 semanas
Ourense, España Endeavour. Inspired Infrastructure. A tiempo completoThermal Works LLC has an exciting opportunity for a Lead Field Service Technician to join our team, working directly with the Thermal Works team as well as local contractors, focusing on Startup/Commissioning and Service for all Thermal Works equipment. We are looking for someone who is a detail-oriented individual that is goal oriented with a foundational...
