Risk Management: Maintain and influence Risk Management Files through the management and evaluation of post-market information from complaints, adverse events, product returns, vigilance reports, customer feedback, literature, registries, CAPA, nonconformances, and other relevant sources to assess potential safety impact, severity, reportability, and investigation requirements. 8+ years of progressive experience within the medical device, pharmaceutical, and combination-product industries, with significant experience in Post Market Surveillance (PMS), complaint handling, vigilance, adverse event reporting, and quality systems.