• Supports the Complaint Manager in managing, coordinating, and continuously improving global complaint handling and post-market surveillance processes for the WiSE CRT System • Acts as a Subject Matter Expert (SME) for complaint investigations, root-cause analysis, and complaint related CAPA’s • Ensures that technical findings are translated into clear, accurate, and meaningful summaries for regulatory audiences • Applies clinical judgment to assess event severity and reportability under various regulations • Leads or contributes to root-cause analyses using methodologies such as 5 Whys, Fishbone, and Fault Tree Analysis • Ensures proper linkage between complaints, CAPAs, and risk management documentation • Compiles, analyzes, and trends complaint data to detect emerging risks, product reliability issues, and safety signals • Develops and maintains Post Market Surveillance Plans, PMS Reports, and Management Review metrics • Acts as audit liaison and subject-matter expert for PMS and complaint-handling processes during internal and external audits