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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
