Global PMO & Data Management Lead (Medical Devices)

Amerit Consulting; California; On-site; USD 110,000 - 140,000; Full time

Job summary

Amerit Consulting is seeking a Project Manager – PMO & Data Management (Medical Devices) in Milpitas, CA, to lead a global regulatory registration and labeling transition within the Biosciences organization.

You will manage cross-functional workstreams across Regulatory Affairs, Quality, R&D, Labeling, and IT, translating requirements into actionable plans, maintaining dashboards, and ensuring on-time delivery in a regulated environment.

Qualifications

• 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 in medical devices, in vitro diagnostics, biotechnology, pharmaceuticals, or another regulated life-sciences environment.
• Demonstrated experience managing project plans, milestones, dependencies, risks, issues, actions, and decisions.
• Familiarity with regulatory documentation, quality systems, labeling, regulatory submissions, product registrations, or related compliance activities.
• Strong analytical, data-management, and cross-functional coordination skills.
• Strong Microsoft Excel skills and proficiency with PowerPoint, Teams, SharePoint, and project-planning or collaboration tools.

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.
• Prepare concise status updates and dashboards highlighting progress, upcoming milestones, overdue items, risks, dependencies, decisions, and required support.

Skills

Analytical skills

Data management

Cross-functional coordination

Excel skills

PowerPoint

Teams

SharePoint

Project planning tools

Education

Bachelor's degree in Business, Science, Engineering, Regulatory Affairs, Operations, Information Systems, or a related discipline

Tools

Smartsheet

Microsoft Project

Power BI

Documentation management

Job description

Amerit Consulting is seeking a Project Manager – PMO & Data Management (Medical Devices) in Milpitas, CA, to lead a global regulatory registration and labeling transition within the Biosciences organization.

You will manage cross-functional workstreams across Regulatory Affairs, Quality, R&D, Labeling, and IT, translating requirements into actionable plans, maintaining dashboards, and ensuring on-time delivery in a regulated environment.