Spec 2, Project/Program Mgmt

Title:Senior Project/Program Manager (Contractor)
Duration: Oct 30, 2026 – Oct 29, 2027
Location: Milpitas, CA 95035 preferred. Remote candidates may be considered based on experience and qualifications

Schedule: 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,

TECHNICAL SKILLS
Must Have
Integrated project planning:

• 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.
• Quality and design control knowledge: Working knowledge of quality management systems, design controls, compliance requirements, and change control.
• Labeling and artwork project management: Experience coordinating labeling changes, artwork development, review and approval workflows, and implementation readiness.

• Proficiency managing risks, actions, issues, decisions, assumptions, and cross-functional dependencies.
• Schedule and critical-path management:
• 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.
• Power BI or comparable dashboard tools:
• 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.

• 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.

• 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.

• 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.

• 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.

• Independently structures ambiguous work and drives it to completion.
• Balances detailed workstream execution with broader program priorities and changing requirements.
• Translates project data into clear insights, decisions, and actions.
• Uses sound judgment in issue resolution, escalation, and prioritization.
• Manages multiple priorities effectively in a fast-moving environment.
• Maintains high standards for detail, data quality, and reporting accuracy.