REMOTE: Senior Project Manager

IntePros; United States; On-site; USD 90,000 - 120,000; Full time

Job summary

A leading medical device firm is seeking an experienced Senior Project Manager to lead system separation initiatives. This role involves managing complex projects, collaborating with various stakeholders, and ensuring compliance with medical device regulations. The ideal candidate should have strong project management skills and experience in a regulated environment, overseeing tasks such as system cloning, data cleansing, and validation. This position offers the opportunity to drive critical changes in a fast-paced setting.

Qualifications

• Experience managing system-focused projects within a medical device or highly regulated environment.
• Strong understanding of regulated systems and compliance expectations.
• Proven ability to manage complex initiatives through separation and transformation timelines.

Responsibilities

• Manage system separation projects through timelines, ensuring delivery aligns with requirements.
• Lead project execution across multiple workstreams, maintaining clear plans and milestones.
• Oversee system cloning, data cleansing, configuration, and validation activities.

Skills

Project management

Regulatory compliance

Cross-functional collaboration

System validation

Stakeholder management

Job description

Overview

Intepros' global medical device client is seeking an experienced Senior Project Manager in the Medical Device space to support critical system separation initiatives. This role will lead the planning, execution, and transition of regulated systems being stood up, cloned, or remediated for the newly formed organization. The ideal candidate brings hands-on experience working within a medical device environment, understands regulated systems and processes, and can confidently manage complex, cross-functional projects through separation timelines.

This role will support multiple system-focused workstreams, including:

• Global Make/Deliver Labeling
• Electronic Instructions for Use (eIFU)
• Global UDI

Responsibilities

• Manage system separation projects through agreed-upon timelines, ensuring delivery aligns with regulatory, quality, and business requirements.
• Lead day-to-day project execution across multiple workstreams, maintaining clear plans, milestones, risks, and dependencies.
• Drive coordination across Quality, Regulatory, Operations, IT, and business stakeholders.
• Oversee system cloning, data cleansing, configuration, and validation activities for NewCo readiness.
• Partner closely with IT to support system design, environment setup, testing, and cutover planning aligned to the new organizational model.
• Ensure system testing (including UAT) is planned, executed, and documented appropriately for a regulated environment.
• Support procedure development, updates, and alignment required for system separation and NewCo operations.
• Ensure documentation meets medical device quality and compliance expectations.
• Develop and execute transition plans to support a smooth handoff of systems, processes, and knowledge to the NewCo organization.
• Facilitate structured knowledge transfer sessions and documentation to ensure long-term sustainability post-separation.
• Act as a key liaison between business teams and IT, ensuring alignment between system capabilities and operational needs.
• Provide clear status updates, issue escalation, and decision support to program and executive stakeholders.

Qualifications

• Experience managing system-focused projects within a medical device or highly regulated environment.
• Strong understanding of regulated systems, validation, and compliance expectations (e.g., labeling, UDI, eIFU).
• Proven ability to lead complex initiatives through separation, carve-out, or transformation timelines.
• Experience partnering closely with IT teams on system implementation, cloning, testing, and deployment.
• Strong project management skills with the ability to operate independently and drive outcomes

Preferred Qualifications

• Direct experience with labeling systems, eIFU platforms, or UDI programs in a global medical device context.
• Experience supporting NewCo stand-up, separation, or divestiture initiatives.
• Familiarity with global Make/Deliver or supply chain-related systems in regulated environments.
• Local to the Raynham, MA area, or able to be onsite in Raynham during the workweek as project needs require.
• Comfortable working in a fast-moving, ambiguous environment typical of separation initiatives.