Project/Program Manager

Kaygen, Inc.; Milpitas (CA); Hybrid; USD 120,000 - 160,000; Full time

Benefits offered by this job

Free Healthcare Insurance

401(k) Retirement Plan

Free Life Insurance

Sick Time Off

Job summary

Kaygen, Inc. is seeking a Project/Program Manager in Milpitas, CA (Remote) to support global regulatory registration and labeling transitions within the Biosciences organization.

You will own workstreams across regions and product groups, coordinating across Regulatory Affairs, Quality, R&D, Labeling, Product, Operations, IT, and Supply Chain. The role emphasizes execution discipline, data management, and clear cross-functional communication, enabling timely milestones and governance decisions.

Qualifications

• Bachelor's degree in business, science, engineering, regulatory affairs, operations, or related field.
• Six or more years of project or program management in a regulated environment.
• Experience in medical devices, IVD, biotechnology, pharmaceuticals, or similar life-sciences.
• Proven ability to develop and maintain project plans with milestones, risks, and decisions.
• Familiarity with dossiers, design controls, quality systems, labeling, submissions, or compliance remediation.

Responsibilities

• Lead assigned workstreams or execution packages, converting objectives into deliverables, milestones, owners, dependencies, and dates.
• Build and maintain detailed project plans across regulatory, labeling, quality, IT, operations, and commercial activities.
• Coordinate deliverables across functions and regions; monitor commitments and close actions in a matrix environment.
• Maintain risks, actions, issues, decisions, assumptions, and dependencies; escalate material impacts as needed.
• Facilitate planning sessions and readiness reviews; document decisions and owners with due dates.
• Support dossier readiness and submissions by coordinating reviews, gaps, remediation, and dependencies.

Skills

Excel

PowerPoint

Power BI

MS Project / Planning tools

Stakeholder management

Cross-functional coordination

Data management

Attention to detail

Communication skills

Education

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

PMP certification

Tools

Smartsheet

Microsoft Project

SharePoint

Teams

Job description

KAYGEN is an emerging leader in providing top talent for technology-based staffing services. We specialize in providing high-volume contingent staffing, direct hire staffing and project-based solutions to companies worldwide ranging from startups to Fortune 500 and Managed Service Providers (MSP) across a wide variety of industries.

Location: Milpitas, California preferred; remote candidates may be considered

Reports To: Director, Integration Program Management

Focus: Global registration and labeling transition

JOB DESCRIPTION:

Position: Project/Program Manager

Location: Milpitas, CA 95035 (Remote)

Duration: 12 months with possible extension

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.

Shift: ['Integrated project planning and scheduling using Smartsheet, Microsoft Project, or equivalent Advanced Excel and structured data management, including lookups, pivot tables, reconciliation, filtering, and data validation RAID and dependency management, including risks, actions, issues, decisions, assumptions, owners, and due dates Regulated life-sciences project execution, with working knowledge of regulatory submissions, technical documentation, design controls, QMS, or labeling Project reporting and governance, including milestone tracking, readiness reporting, dashboards, and concise status reporting']

Start: ['Global medical device or IVD registration experience, particularly registration or re-registration programs Product/SKU and country-level data management, including large datasets with multiple regional contributors Power BI or advanced dashboard/reporting capability Workflow automation, such as Power Automate or comparable tools PMP, CAPM, or equivalent project management certification']

At KAYGEN, people are at the heart of everything we do. We foster a diverse, inclusive, and employee-driven culture where every individual is valued, empowered, and encouraged to bring their authentic self to work. Our candidate-first approach means we are committed to understanding your career goals and connecting you with opportunities that align with your aspirations, skills, and potential. Whether you're taking the next step in your career or searching for your dream opportunity, KAYGEN is more than a staffing partner—we're a community dedicated to helping you grow, succeed, and thrive. Join us and discover a place where your talent is recognized, your ambitions are supported, and your future is built alongside a team that invests in your success every step of the way.

Our team of experienced staffing experts will work with you to find you the best opportunity. For more information, please visit us at www.kaygen.com.

Benefits

• Free Healthcare Insurance
• 401(k) Retirement Plan
• Free Life Insurance
• Sick Time Off