The incumbent delivers written documentation of safety assessments, supports the response to queries from regulatory agencies in relation to global vigilance reports (including U.S MDR filings), provides technical writing expertise and leadership to the generation of post market safety reports (such as PSUR and CSR), provides clinical/medical input to other post market surveillance activities, and serves on multifunctional teams. This individual will provide support to internal functional teams and groups, such as those responsible for complaint evaluation, reportability determination, complaint investigation, health hazard evaluation, risk file review, CAPA, and field actions.