Responsible for remediating risk management files for Class III medical devices to comply with 2019 version of ISO 14971; supporting the development of new templates for risk management file in alignment with ISO 14971:2019; developing efficient timelines for risk remediation activities and providing training to support teams; conducting comprehensive gap analysis and remediating for design controls, risk management file; upgrading in-house inspection equipment which reduced inspection time and, in some cases, generated minimal errors due to poka-yoke setup; providing regulatory responses; collaborating on root cause investigations, CAPA, and health hazard evaluations, offering design and risk insights to address in-house/on-field production defects.