Specialist, Quality Compliance

.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 that include moderately complex scenarios:o 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 as appropriateo Seek information and input, and challenge as appropriate, from Product Safety, Engineering and otherdepartments/business units for complaint investigationso Evaluate complaints for Medical Device Reporting to competent authoritieso Prepare and submit reports to Competent Authorities, after review by more senior team member 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 memberMay plan agenda for and run meetings to discuss complaint issues with affected functions (e.G., Manufacturing, Quality Assurance, Suppliers, etc