Project Manager – PMO & Data Management (Medical Devices)

Amerit Consulting; California; On-site; USD 110,000 - 140,000; Full time

Job summary

Amerit Consulting is seeking a Project Manager – PMO & Data Management (Medical Devices) in Milpitas, CA, to lead a global regulatory registration and labeling transition within the Biosciences organization.

You will manage cross-functional workstreams across Regulatory Affairs, Quality, R&D, Labeling, and IT, translating requirements into actionable plans, maintaining dashboards, and ensuring on-time delivery in a regulated environment.

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 in medical devices, in vitro diagnostics, biotechnology, pharmaceuticals, or another regulated life-sciences environment.
• Demonstrated experience managing project plans, milestones, dependencies, risks, issues, actions, and decisions.
• Familiarity with regulatory documentation, quality systems, labeling, regulatory submissions, product registrations, or related compliance activities.
• Strong analytical, data-management, and cross-functional coordination skills.
• Strong Microsoft Excel skills and proficiency with PowerPoint, Teams, SharePoint, and project-planning or collaboration tools.

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.
• Prepare concise status updates and dashboards highlighting progress, upcoming milestones, overdue items, risks, dependencies, decisions, and required support.

Skills

Analytical skills

Data management

Cross-functional coordination

Excel skills

PowerPoint

Teams

SharePoint

Project planning tools

Education

Bachelor's degree in Business, Science, Engineering, Regulatory Affairs, Operations, Information Systems, or a related discipline

Tools

Smartsheet

Microsoft Project

Power BI

Documentation management

Job description

Job Title

Project Manager – PMO & Data Management (Medical Devices)

Location

Milpitas, California (Onsite preferred; remote candidates may be considered for exceptional qualifications)

Duration

12+ months

Reports To

Director, Integration Program Management

Focus

Global Registration and Labeling Transition

Schedule

• Pacific Standard Time (PST) hours preferred.
• Onsite work in Milpitas, California, is preferred.
• Remote arrangements may be considered for exceptional candidates.

Must-Have Requirements

• Bachelor's degree in Business, Science, Engineering, Regulatory Affairs, Operations, Information Systems, or a related discipline.
• Minimum 6 years of project or program management experience, including cross-functional project execution in a regulated environment.
• Experience in medical devices, in vitro diagnostics (IVD), biotechnology, pharmaceuticals, or another regulated life-sciences environment.
• Demonstrated experience managing project plans, milestones, dependencies, risks, issues, actions, and decisions.
• Familiarity with regulatory documentation, quality systems, labeling, regulatory submissions, product registrations, or related compliance activities.
• Strong analytical, data-management, and cross-functional coordination skills.
• Strong Microsoft Excel skills and proficiency with PowerPoint, Teams, SharePoint, and project-planning or collaboration tools.

Job Description

The Project/Program Manager will support the planning and execution of a global regulatory registration and labeling transition program within the Biosciences organization.

The position will be responsible for managing defined workstreams, regions, product groups, or execution packages while coordinating 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 activities, and elevate material risks or decisions through established governance processes.

The successful candidate will demonstrate strong execution discipline, data-management capabilities, attention to detail, and effective cross-functional communication skills.

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 highlighting 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 opportunities to improve project controls, data quality, reporting consistency, and recurring workflows.

Minimum 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.

Additional Qualifications

• 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.

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.

Company Overview

Amerit Consulting is an extremely fast-growing staffing and consulting firm. Amerit Consulting was founded in 2002 to provide consulting, temporary staffing, direct hire, and payrolling services to Fortune 500 companies nationally; as well as small to mid-sized organizations on a local & regional level. Currently, Amerit has over 2,000 employees in 47 states. We develop and implement solutions that help our clients operate more efficiently, deliver greater customer satisfaction, and see a positive impact on their bottom line. We create value by bringing together the right people to achieve results. Our clients and employees say they choose to work with Amerit because of how we work with them - with service that exceeds their expectations and a personal commitment to their success. Our deep expertise in human capital management has fueled our expansion into direct hire placements, temporary staffing, contract placements, and additional staffing and consulting services that propel our clients’ businesses forward.

Amerit Consulting provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training. Applicants, with criminal histories, are considered in a manner that is consistent with local, state and federal laws.