Spec 2, ProjectProgram 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.

• Bachelors 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.