Project/Program Manager

KAYGEN•Milpitas, CA

11h•Remote

About The Position

The Project/Program Manager will support planning and execution of a global regulatory registration and labeling transition program within the Biosciences organization, focused on Project Artemis. The role owns assigned workstreams, regions, product groups, or execution packages, coordinating activities across Regulatory Affairs, Quality, R&D, Labeling, Product, Operations, Supply Chain, Commercial, IT, and regional teams. The position translates requirements into actionable plans, maintains accurate project data, tracks milestones and dependencies, drives follow-up, and escalates material risks or decisions through established governance. The role requires execution discipline, data-management capability, attention to detail, and effective cross-functional communication. The position is based in Milpitas, California, with remote candidates also considered. The stated duration is 12 months, with a possible extension, and the role reports to the Director, Integration Program Management.

Requirements

Bachelor's degree in business, science, engineering, regulatory affairs, operations, information systems, or a related discipline.
At least six 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 at least one 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 consolidating, reconciling, validating, and maintaining 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.

Nice To Haves

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.
Power BI or advanced dashboard/reporting capability.
Workflow automation experience, such as Power Automate or comparable tools.
Experience with large product/SKU and country-level datasets involving multiple regional contributors.

Responsibilities

Lead assigned workstreams or execution packages by defining deliverables, milestones, owners, dependencies, and target dates.
Build and maintain detailed project plans aligned with integrated timelines for 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.
Coordinate technical dossier and documentation readiness activities, including reviews, gap assessments, remediation, and submission-related dependencies with subject matter experts.
Maintain and reconcile product, SKU, country, registration, naming, priority, lifecycle, and schedule information, resolving missing, duplicate, inconsistent, or outdated data.
Prepare status updates and dashboards covering progress, upcoming milestones, overdue items, risks, dependencies, decisions, and required support.
Reflect approved decisions and changes in plans, trackers, governance materials, and stakeholder communications.
Identify opportunities to improve project controls, data quality, reporting consistency, and recurring workflows.