Spec 2, Project/Program Mgmt

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

Location : Milpitas, CA

1st Shift

Note:

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 escalate 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 escalate 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priority, lifecycle, and schedule information; reconcile inputs and resolve missing, duplicate, inconsistent, or outdated data.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.