Job descriptionLead high-impact projects supporting IVDR changes in partnership with Product Transfer, Regulatory, and Quality teams.Drive collaboration across internal teams and third-party manufacturers (TPMs) to align deliverables and timelines.Plan and execute projects from initiation to completion, ensuring scope, timeline, and budget goals are met.Host regular meetings with clear agendas, task ownership, and milestone tracking.Identify risks early and develop mitigation plans to avoid project delays.Manage multiple projects simultaneously while maintaining a high standard of quality and compliance.Apply PFMEA methodologies to improve product reliability and drive proactive change.Support continuous process improvements to enhance project efficiency and business outcomes.Basic Requirements:Associate’s Degree in Project Management or equivalent experience.Minimum 3 years of professional experience in project management.Proficient in Microsoft Office Suite (Excel, PowerPoint, Power BI, Microsoft Project).Preferred Experience:1+ years in a regulated environment (FDA, ISO, IVDR, etc.).Background in medical device, diagnostics, or durable medical equipment manufacturing.Lean Six Sigma training or certification is a plus.