ppDescripción del trabajo Imagine how your ideas and expertise can change a patient's life. Our Quality teams help shape the development of groundbreaking technologies to ensure each stage of our innovation process is held to the highest standards of integrity and safety. You'll bring your passion for problem solving and partner with various teams to influence decision‑making for a product's entire lifecycle. Your work will involve you optimizing product development to impact patients around the world with pioneering technology. /p h3Responsibilities /h3 ul liFulfill applicable medical device regulations in the region, ISO13485 and other relevant requirements for designated complaint handling unit, and evaluation of events for reportability to applicable regulatory bodies. /li liInvestigate complaints with the support of higher level team members or manager. /li liEvaluate event to determine if it qualifies as a complaint. /li liManage customer relationship and expectations during the course of complaint investigation and resolution process. /li liAssess complaint information provided and conduct additional investigation as needed and escape as appropriate. /li liEvaluate complaints for Medical Device Reporting to competent authorities. /li liPrepare and submit reports to Competent Authorities, after review by a more senior team member. /li liSummarize findings, including a review of the investigation, product analysis, imaging review, instructions for use (IFU), and any other relevant labeling and/or training materials, and formulate conclusions. /li liPrepare and submit final customer correspondence, after review by a more senior team member. /li liOther incidental duties; may identify problems with processes, procedures, and/or practices, and recommend solutions, including devising new approaches to problems encountered.



/li liAdhere to all company rules and requirements (e.G., pandemic protocols, Environmental Health Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control. /li /ul h3Required Qualifications /h3 ul liBachelor's Degree in a related field, 1 year experience with complaint handling experience. /li liExperience working in a medical device (cardiovascular, endovascular, or other critical care/surgical products), healthcare, or a related environment. /li /ul h3Preferred Qualifications /h3 ul liGood computer skills in MS Office Suite and ability to operate general office machinery. /li liGood written and verbal communication skills and interpersonal relationship skills. /li liGood problem‑solving and critical thinking skills. /li liBasic knowledge of medical terms and human anatomy. /li liFull knowledge of Medical Device Vigilance regulations, and regulatory reporting regulations. /li liGood knowledge of Good Documentation Practices (GDP) as it relates to complaint filing. /li liAbility to manage confidential information with discretion. /li liAttention to detail. /li liAbility to interact professionally with all organizational levels. /li liAbility to manage competing priorities in a fast‑paced environment with guidance. /li liMust be able to work in a team environment, including immediate supervisor and other team members in the section or group. /li liAbility to build stable internal/external working relationships. /li /ul pICON plc is a world-leading healthcare intelligence and clinical research organization.We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join u... Mostrar más /p /p #J-18808-Ljbffr

📌 Associate Specialist, Quality Compliance (Madrid)
🏢 PVH
📍 Madrid