Senior Project/Program Manager

The hiring client is a confidential medical device manufacturing company. The Senior Project/Program Manager will support a global regulatory registration and product transition program and other strategic integration initiatives, coordinating cross-functional plans, dependencies, risks, reporting, and decisions.

Responsibilities:

• Lead assigned projects and workstreams, translating program objectives into clear scope, deliverables, milestones, owners, dependencies, and target dates
• Build and maintain integrated project plans that align regulatory, technical documentation, labeling, quality, R&D, operations, supply chain, commercial, and IT activities
• Coordinate across functional leaders and subject matter experts, monitor commitments, resolve planning gaps, and drive completion of deliverables in a matrix environment
• Identify and manage risks, issues, actions, decisions, assumptions, schedule conflicts, and resource constraints
• Assess the downstream impact of changes and delays, establish mitigation plans with accountable owners, and escalate material items through appropriate governance channels
• Facilitate cross-functional planning sessions, working meetings, risk reviews, and decision discussions
• Ensure meeting outcomes, approved decisions, and changes are reflected in project plans, reporting, and communications
• Apply working knowledge of technical dossiers, design controls, labeling, quality systems, and regulatory submissions to support appropriate planning, sequencing, documentation readiness, and submission readiness
• Prepare concise status updates for project teams and leadership, highlighting progress, upcoming milestones, overdue actions, risks, dependencies, decisions, and required support
• Design and maintain practical project databases, trackers, dashboards, and reporting processes
• Consolidate information from multiple workstreams and analyze project data to identify trends, emerging risks, and areas requiring leadership attention
• Improve the quality, consistency, and efficiency of program reporting, including opportunities to simplify or automate recurring data collection

Requirements:

• Ability to build and maintain detailed plans covering scope, deliverables, milestones, dependencies, owners, resources, and target dates
• Experience managing complex projects in medical devices, in vitro diagnostics, pharmaceuticals, or another regulated environment
• Working knowledge of global product registrations, re-registrations, submission readiness, and regulatory documentation processes
• Familiarity with dossier development, document readiness, review cycles, submission inputs, and approval dependencies
• Working knowledge of quality management systems, design controls, compliance requirements, and change control
• Experience coordinating labeling changes, artwork development, review and approval workflows, and implementation readiness
• Proficiency managing risks, actions, issues, decisions, assumptions, and cross-functional dependencies
• Ability to identify sequencing constraints, schedule conflicts, downstream impacts, and critical-path risks
• Experience designing and maintaining structured project databases, trackers, and reliable reporting processes
• Strong capability with formulas, pivot tables, lookups, data validation, reconciliation, and analysis
• Ability to develop and maintain dashboards that communicate milestones, overdue deliverables, risks, trends, and leadership actions
• Proficiency with Microsoft PowerPoint, Teams, SharePoint, and project-planning platforms such as Smartsheet or Microsoft Project
• Bachelor's degree in business, science, engineering, operations, information systems, or a related discipline
• Ten or more years of progressive project or program management experience
• Experience managing complex, cross-functional projects or workstreams in a regulated life sciences environment
• Demonstrated experience managing integrated plans, milestones, dependencies, risks, issues, decisions, and accountability across multiple functions
• Working knowledge of technical dossiers, design controls, labeling, quality systems, and regulatory submission processes
• Strong analytical and data management capabilities, including experience developing project databases, dashboards, and data-driven reporting solutions
• Advanced proficiency with Excel and strong proficiency with Power BI or a comparable data visualization tool
• Proficiency with PowerPoint, Teams, SharePoint, and project planning or collaboration tools
• Strong written, verbal, facilitation, presentation, and stakeholder management skills
• Ability to influence and drive accountability without direct authority
• PST hours preferred at least 10 years' experience
• Experience with Acquisitions and Mergers, working with large global teams
• PMP certification
• Experience with Product Registration, Labeling and Regulatory Submissions
• Direct experience with global medical device or in vitro diagnostic product registrations and re-registrations. Experience coordinating technical dossier development, remediation, review, and submission readiness
• Familiarity with labeling and artwork management systems, including review and approval workflows
• Experience supporting quality management system, design control, change control, or compliance remediation initiatives
• Experience managing product transitions, including dependencies across regulatory, quality, operations, supply chain, commercial, and IT teams
• Experience supporting M&A integration, business transformation, or enterprise-level programs
• Experience working with global teams across multiple regions, business units, and time zones
• Working knowledge of Smartsheet, Microsoft Project, Microsoft Planner, or comparable project-planning tools
• Experience with SharePoint-based data structures, document libraries, and program reporting
• Experience automating reporting or workflows using Power Query, Power Automate, or comparable tools
• Direct experience supporting global medical device or in vitro diagnostic product registrations or re-registrations
• Experience supporting regulatory submissions, technical documentation readiness, labeling transitions, or compliance remediation programs
• Experience with business integration, transformation, M&A, or other enterprise-level initiatives
• Experience working with global teams across multiple functions, regions, or business units
• PMP, PgMP, or equivalent project management certification