Spec 2, Project/Program Mgmt

MillenniumSoft Inc; 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

Position

Project/Program Manager - Supporting projects in med devices, in vitro diagnostics, biotechnology, pharmaceuticals

Location

Milpitas, CA

Shift

1st Shift

Pay Rate

Pay Rate: $50-$55

Pst hours preferred at least 6 years experience On site preferred but for a stellar candidate we can do remote .

Position Summary

• The Project/Program Manager will support planning and execution for global regulatory registration and labeling transition program within the Biosciences organization.
• The role will own defined workstreams, regions, product groups, or execution packages and coordinate activities across Regulatory Affairs, Quality, R&D, Labeling, Product, Operations, Supply Chain, Commercial, IT, and regional teams.
• The Project/Program Manager will translate requirements into actionable plans, maintain accurate project data, track milestones and dependencies, drive follow-up, and elevate material risks or decisions through established governance.
• The successful candidate will combine strong execution discipline, data-management capability, attention to detail, and effective cross-functional communication.

Key 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 elevate 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.

Required 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 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.

Preferred Qualifications

• 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.

Core Capabilities

• 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.