Lead Vigilance and QARA Spain

Lead 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 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 authorityAct as the representative for the regions under their responsibilitySupport activities for global vigilance reporting such asProcess, 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 determines how to present the data most effectively in a succinct manner.Attend/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 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 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 Spain**Education and Experience:****Minimum Requirements:**Relevant 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 regulations, BA/BS degreeEffective 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 mannerStrong attention to detail with excellent grammatical, editorial, and proofreading skillsSpanish 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