.Fulfill 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.How you will make an Impact:
- Investigate complaints with the support of higher level team member or managero Evaluate event to determine if it qualifies as a complainto Manage customer relationship and expectations during course of complaint investigation and resolution processo Assess complaint information provided and conduct additional investigation as needed and escalate asappropriateo Evaluate complaints for Medical Device Reporting to competent authoritieso Prepare and submit reports to Competent Authorities, after review by more senior team membero Summarize 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 conclusionso Prepare and submit final customer correspondence, after review by more senior team member
- Other incidental duties; May identify problems with processes, procedures, and/or practices, and recommend solutions, including devising new approaches to problems encounteredWhat you will need:Bachelor's Degree in related field, 1 year experience complaint handling-similar experienceExperience working in a medical device (cardiovascular, endovascular, or other critical care/surgical products), healthcare, or a related environmentWhat else we look for:Good computer skills in MS Office Suite and ability to operate general office machineryGood written and verbal communication skills and interpersonal relationship skillsGood problem-solving and critical thinking skillsModerate knowledge and understanding of Edwards policies, procedures, and guidelines relevant to quality complianceBasic knowledge of medical terms and human anatomyFull knowledge of Medical Device Vigilance regulations, and regulatory reporting regulationsGood knowledge of Good Documentation Practices (GDP) as it relates to complaint filingAbility to manage confidential information with discretionAttention to detailAbility to interact professionally with all organizational levelsAbility to manage competing priorities in a fast paced environment with guidanceMust be able to work in a team environment, including immediate supervisor and other team members in the section or groupAbility to build stable internal/external working relationshipsAdhere to all company rules and requirements (e.G
