Regulated Life Sciences Project & Program Lead

Millenniumsoft; Milpitas (CA); On-site; USD 69,000 - 76,000; Full time

Job summary

Millenniumsoft in Milpitas, CA seeks a Project/Program Manager to drive global regulatory registration and labeling transitions for medical devices, IVDs, biotech, and pharma projects.

The role owns defined workstreams across Regulatory Affairs, Quality, R&D, Labeling, Product, Operations, Supply Chain, IT and regional teams; you translate requirements into actionable plans and maintain accurate project data with clear milestones.

Qualifications

• Bachelor’s degree in a related field and 6+ years in project/program management in regulated environments.
• Experience supporting medical devices, IVDs, biotech, or pharma projects.
• Ability to develop and maintain project plans, milestones, risks, and decisions.
• Familiarity with dossiers, design controls, quality systems, labeling, or regulatory submissions.
• Experience coordinating across functions and driving follow-up in a matrix organization.
• Strong analytical, data-management, and communication skills.

Responsibilities

• Lead assigned workstreams, turning objectives into deliverables, milestones, owners, dependencies, and due dates.
• Create and maintain detailed project plans across regulatory, labeling, quality, product, ops, and IT.
• Coordinate across functional and regional stakeholders; monitor commitments and close actions on time.
• Manage risks, actions, issues, decisions, assumptions, and dependencies; escalate as needed.
• Facilitate planning sessions and readiness reviews; document decisions and owners with due dates.
• Support regulatory dossiers and documentation readiness by coordinating reviews and gaps.
• Maintain product, SKU, country, registration, naming, and lifecycle data; reconcile data inputs.
• Prepare status dashboards highlighting progress, milestones, risks, and required support.
• Ensure changes are reflected in plans, governance materials, and stakeholder communications.
• Identify opportunities to improve project controls, data quality, and workflows.

Skills

Cross-functional collaboration

Regulated environment experience

Project planning

Data-management

Stakeholder management

Analytical skills

Education

Bachelor's degree in business/science/engineering/regulatory affairs/operations

Tools

Smartsheet

Microsoft Project

Power BI

Excel

PowerPoint

Teams

SharePoint

Job description

Millenniumsoft in Milpitas, CA seeks a Project/Program Manager to drive global regulatory registration and labeling transitions for medical devices, IVDs, biotech, and pharma projects.

The role owns defined workstreams across Regulatory Affairs, Quality, R&D, Labeling, Product, Operations, Supply Chain, IT and regional teams; you translate requirements into actionable plans and maintain accurate project data with clear milestones.