Risk Management: Maintain the Risk Management Files through management and evaluation of post-market information from complaints, adverse events, product returns, vigilance reports, customer feedback, literature, registries, CAPA, NC and other relevant sources to determine potential safety impact, severity, reportability, and investigation requirements. 5+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.