Project/Program Manager

KAYGEN is recruiting for a confidential client for a Project/Program Manager to support a global regulatory registration and labeling transition program within its Biosciences organization. The role leads assigned workstreams, coordinates cross-functional and regional stakeholders, maintains project plans and data, and tracks risks, dependencies, and milestones.

Responsibilities:

• Lead assigned workstreams or execution packages, converting objectives into clear deliverables, milestones, owners, dependencies, and target dates
• Build and maintain detailed project plans aligned with the integrated timeline, including regulatory, technical documentation, labeling, quality, product, operational, commercial, and IT activities
• Coordinate deliverables across functional and regional stakeholders; monitor commitments, follow up on  actions, and drive timely closure in a matrix environment
• Maintain risks, actions, issues, decisions, assumptions, and dependencies; assess downstream impacts and escalate material schedule, resource, compliance, or scope concerns
• Facilitate planning sessions, working meetings, readiness reviews, and risk discussions; document decisions, action items, owners, and due dates
• Support technical dossier and documentation readiness by coordinating reviews, gap assessments, remediation activities, and submission-related dependencies with functional subject matter experts
• Maintain accurate product, SKU, country, registration, naming, priority, lifecycle, and schedule information; reconcile inputs and resolve missing, duplicate, inconsistent, or outdated data
• Prepare concise status updates and dashboards that highlight progress, upcoming milestones, overdue items, risks, dependencies, decisions, and required support
• Ensure approved decisions and changes are reflected in plans, trackers, governance materials, and stakeholder communications
• Identify practical opportunities to improve project controls, data quality, reporting consistency, and recurring workflows

Requirements:

• Bachelor's degree in business, science, engineering, regulatory affairs, operations, information systems, or a related discipline
• Six or more years of project or program management experience, including cross-functional project execution in a regulated environment
• Experience supporting projects in medical devices, in vitro diagnostics, biotechnology, pharmaceuticals, or another regulated life-sciences environment
• Demonstrated experience developing and maintaining project plans, milestones, dependencies, risks, issues, actions, and decisions
• Working familiarity with one or more of the following: technical dossiers or files, design controls, quality systems, labeling, regulatory submissions, product registrations, documentation readiness, or compliance remediation
• Experience coordinating deliverables across multiple functions and driving timely follow-up and accountability in a matrix organization
• Strong analytical and data-management skills, including the ability to consolidate, reconcile, validate, and maintain information from multiple contributors
• Strong Excel skills and proficiency with PowerPoint, Teams, SharePoint, and project-planning or collaboration tools
• Strong organization, facilitation, written communication, and stakeholder-management skills
• Ability to manage multiple priorities while maintaining accuracy, follow-through, confidentiality, and appropriate escalation
• Structured execution: translates defined objectives into practical plans and follow-up mechanisms
• Data quality and attention to detail: identifies gaps, conflicts, and inconsistencies and drives resolution
• Cross-functional coordination: builds alignment and accountability without direct authority
• Risk and dependency management: recognizes downstream impacts and escalates at the appropriate level
• Judgment: resolves routine execution issues independently while escalating regulatory judgments, prioritization decisions, scope changes, and material timeline risks
• Adaptability: maintains control as priorities, sequencing, inputs, and assumptions evolve
• Integrated project planning and scheduling using Smartsheet, Microsoft Project, or equivalent
• Advanced Excel and structured data management, including lookups, pivot tables, reconciliation, filtering, and data validation
• RAID and dependency management, including risks, actions, issues, decisions, assumptions, owners, and due dates
• Regulated life-sciences project execution, with working knowledge of regulatory submissions, technical documentation, design controls, QMS, or labeling
• Project reporting and governance, including milestone tracking, readiness reporting, dashboards, and concise status reporting
• Experience supporting global medical device or IVD registrations, re-registrations, technical-documentation readiness, labeling transitions, or compliance remediation
• Experience managing high-volume product, SKU, country, registration, naming, or lifecycle data
• Experience working with global teams across multiple functions, regions, or business units
• Experience with Smartsheet, Microsoft Project, Power BI, product lifecycle management, document management, or comparable planning and reporting tools
• Experience supporting business integration, transformation, separation, or M&A-related initiatives
• PMP, CAPM, or equivalent project-management certification
• Global medical device or IVD registration experience, particularly registration or re-registration programs
• Product/SKU and country-level data management, including large datasets with multiple regional contributors
• Power BI or advanced dashboard/reporting capability
• Workflow automation, such as Power Automate or comparable tools
• PMP, CAPM, or equivalent project management certification