• Serve as a clinical and technical subject matter expert within Quality Assurance and provides advanced clinical expertise to assess device performance concerns, determine regulatory reportability, identify root causes, and support risk management activities. • Play a key role in ensuring regulatory compliance, identifying safety signals, and supporting product quality and patient safety. • Collaborate cross-functionally with Quality, Regulatory Affairs, R&D, Manufacturing, and Clinical teams to evaluate complaints, interpret clinical and device data, and ensure accurate, compliant complaint handling in accordance with FDA, EU MDR, and other global regulatory requirements. • Partner closely with Field Clinical and Technical teams to ensure timely reporting of device-related issues and collection of complete, high-quality information to support thorough complaint investigation and evaluation. • Act as senior clinical and technical SME for complaint investigations involving implantable medical devices including assessment of device performance and patient outcomes. • Support Quality Leadership in identifying emerging product performance trends, reliability concerns, and potential risk signals through complaint trending and data analysis. • Perform global regulatory reportability assessments in accordance with applicable regulations, including FDA Medical Device Reporting (21 CFR 803), EU MDR Vigilance Reporting, TGA, PMDA, MHRA, and other international regulatory requirements. • Provide clinical and technical input to support regulatory submissions, responses to Competent Authority inquiries, and vigilance reporting activities. • Participate in cross-functional reviews of complaint trends, product performance, reliability, and patient safety. • Support internal audits, external audits, and regulatory inspections related to complaint handling, vigilance reporting, and post-market surveillance activities. • Drive continuous improvement of post-market surveillance (PMS) and complaint handling processes.