• Supports the development and implementation of the global regulatory requests for additional information communication process and activities • Supports and monitors the completion of regulator requests for additional information to the US FDA, and other Regulatory Authorities as applicable • Supports and contributes in cross functional teams on investigating, assessing and authoring responses • Tracks, trends, and analyzes requests for additional information from regulators, respective corrective actions, and remediations; provide inputs to upstream processes for improvements • Gathers, collates, and maintains AIR weekly report; distributes and presents to internal stakeholders • Identifies issues that require prompt notification and presents/communicates to Olympus senior leadership in a clear and concise manner • Escalates potential safety issues for risk assessment or health hazard assessment • Supports and contributes the development of Global AIR communications • Works together with the Customer Quality organization to identify, access, and analyze data that have impact on the company’s compliance with overall quality systems • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues • Advise management on potential improvements or enhancement to quality systems and processes in the company • Develops new approaches to solve problems identified as part of the team • Participates in the implementation of Global Customer Quality initiatives and programs throughout the Global organization, as required • Participates in the CAPA process as required as an assignee or project team member • Perform other duties as assigned.