Project Manager - Post Market Products

Lead post-market surveillance for DEKA medical devices, coordinating complaint handling, MDR submissions, CAPA escalation and closure, PMCF plans, and PSURs to ensure compliance with FDA/21 CFR Part 803/820, EU MDR, CMDR, and related standards. Develop and maintain detailed project plans, dashboards, and status updates; drive cross-functional collaboration across engineering, quality, manufacturing, and regulatory teams to ensure timely investigations and CAPA closure. Prepare and maintain Post Market Surveillance Plans, PMCF plans, and PSURs; monitor signals from complaints, MDRs, service data, and literature; support interactions with FDA, Notified Bodies, and regulators; assist regulatory affairs to meet post-market reporting obligations across markets. Build post-market performance dashboards and metrics for senior leadership; support audits and inspections; author procedures governing post-market quality activities aligned with QMS (ISO 13485, ISO 14971). Strong communications, data analysis, and problem-solving skills in a dynamic R&D environment.