Sr. Project Manager – eIFU Implementation

IntePros; West Chester (Chester County); On-site; USD 120,000 - 160,000; Full time

Job summary

IntePros in the United States is seeking a Senior Project Manager to lead the implementation and deployment of an electronic Instructions for Use (eIFU) platform for a global medical device client. You will manage data separation, migration, validation, and coordination with regulatory, quality, IT, labeling, and product teams.

The role requires strong PM experience in regulated environments, vendor management, and ability to collaborate with teams across the U.S., Europe, and Asia.

Qualifications

• PM experience in regulated medical device environments
• Experience implementing or migrating eIFU/eIFU platforms
• Knowledge of regulated product documentation, labeling, and data governance

Responsibilities

• Lead end-to-end PM of eIFU platform implementation, including planning, requirements, timelines, risks, testing, validation, and deployment
• Manage transition from internal eIFU to third-party platform, including data separation, migration, mapping, cleansing, and validation
• Serve as primary liaison between internal stakeholders and the eIFU technology/vendor partner
• Coordinate cross-functional activities across Regulatory Affairs, Quality, IT, Labeling, Product Management, Data Management and others
• Develop and maintain project plans, milestones, risk/issue logs, status reporting, action items, and implementation documentation
• Support platform configuration, integration, testing, validation, user acceptance testing, and production readiness
• Ensure activities meet medical device regulatory, quality, documentation, and data governance requirements
• Coordinate stakeholders across U.S., Europe, and Asia; manage multi-time-zone dependencies
• Support change management, training, process docs, and transition activities
• Identify risks and drive issues to closure for compliant implementation

Skills

Project management

Regulated environment

Stakeholder management

Cross-functional leadership

Vendor management

eIFU platforms

IFUcare

Tools

eIFU platforms

IFUcare

Job description

IntePros is partnered with a global medical device client to identify an experienced Senior Project Manager to support the implementation and deployment of an electronic Instructions for Use (eIFU) platform. This individual will lead the transition from an existing internally managed eIFU environment to a third-party platform, including the separation, migration, and validation of data and documentation. The ideal candidate will bring strong project management experience within the medical device/MedTech industry, with direct experience implementing or deploying eIFU systems, IFU platforms, labeling/document management solutions, or similar regulated digital content platforms. Location: West Chester, PA strongly preferred. Candidates in the Eastern or Central U.S. time zones may also be considered due to significant collaboration with teams and vendors in Europe and Asia.

Responsibilities

• Lead the end-to-end project management of an eIFU platform implementation, including project planning, requirements gathering, timelines, dependencies, risks, testing, validation, and deployment.
• Manage the transition from an existing internal eIFU environment to a third-party platform, including data separation, migration, mapping, cleansing, and validation activities.
• Serve as the primary liaison between internal stakeholders and the selected eIFU technology/vendor partner.
• Coordinate cross-functional activities across Regulatory Affairs, Quality, IT, Labeling, Product Management, Data Management, and other business teams.
• Develop and maintain project plans, milestones, risk/issue logs, status reporting, action items, and implementation documentation.
• Support platform configuration, integration, testing, validation, user acceptance testing, and production readiness.
• Ensure implementation activities align with applicable medical device regulatory, quality, documentation, and data governance requirements.
• Coordinate stakeholders across the U.S., Europe, and Asia and manage dependencies across multiple time zones.
• Support change management, training, process documentation, and transition activities associated with the new platform.
• Identify project risks and proactively drive issues through resolution to ensure a successful and compliant implementation.

Qualifications

• Demonstrated Project Management experience, ideally supporting technology or digital transformation initiatives within medical devices, MedTech, life sciences, or another highly regulated environment.
• Experience implementing, deploying, or migrating eIFU (electronic Instructions for Use) platforms is strongly preferred.
• Experience with IFUcare is a significant plus.
• Knowledge of IFU/eIFU processes, regulated product documentation, labeling, document management, or regulatory content management is highly desirable.
• Experience managing data migration or system transition projects, including data mapping, validation, and separation from legacy or shared environments.
• Demonstrated ability to manage external technology vendors and coordinate complex cross-functional project teams.
• Understanding of validation, quality, compliance, and documentation requirements within a regulated medical device environment.
• Strong stakeholder management, communication, organization, and problem-solving skills.
• Ability to effectively collaborate with global teams across the U.S., Europe, and Asia.

Preferred Background

Candidates with previous experience supporting large global medical device organizations and implementing enterprise eIFU solutions will be particularly well aligned. Experience working directly with IFUcare or comparable third-party eIFU platforms would be highly valuable.