Sr. Project Coordinator, Medical Device

Our global medical device client is seeking a Senior Project Coordinator to support critical system separation initiatives. This role will directly support director level leadership across Quality, R&D, and Regulatory Affairs, ensuring alignment, visibility, and execution across highly regulated work streams. The Project Coordinator will play a key role in managing cross-functional dependencies, tracking readiness activities, and supporting the successful separation of regulated systems, including:

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

This role is ideal for someone with experience in medical device environments who thrives in complex, matrixed programs and can bring structure, clarity, and momentum to fast-moving separation efforts.

Responsibilities

• Provide direct project coordination and operational support to Director-level leaders overseeing Quality, R&D, and Regulatory Affairs work streams.
• Prepare meeting materials, status reports, dependency trackers, and decision logs for senior stakeholders.
• Proactively identify gaps, risks, and misalignments requiring escalation or clarification.
• Ensuring activities remain aligned across functions.
• Maintain and manage cross-functional dependency maps, timelines, and readiness indicators.
• Track upstream and downstream impacts of system, process, or regulatory changes and surface risks early.
• Support coordination of system cloning, data cleansing, testing, and New Co readiness activities in partnership with IT and business teams.
• Assist with tracking testing cycles, validation milestones, and issue resolution for regulated systems.
• Ensure dependencies between system work streams and functional deliverables are clearly understood and documented.
• Support the development, alignment, and tracking of procedures required for system separation and New Co operations.
• Ensure documentation inputs from Quality, R&D, and Regulatory Affairs are coordinated and delivered on time.
• Assist in developing and tracking transition plans and knowledge transfer activities to support New Co readiness.
• Coordinate documentation and knowledge-sharing sessions to ensure continuity post-separation.
• Partner with IT and functional teams to ensure alignment with the new organizational model and system design.
• Track actions, decisions, and interdependencies across business and IT teams to support integrated delivery.

Qualifications

• Experience supporting complex, cross-functional projects in a medical device or highly regulated environment.
• Strong organizational and coordination skills, with experience supporting senior or Director-level stakeholders.
• Working knowledge of Quality, R&D, and Regulatory Affairs processes and how they intersect in medical device organizations.
• Ability to manage interdependencies across multiple work streams and functions.
• Excellent communication skills, with the confidence to engage across levels of the organization.

Preferred Qualifications

• Experience supporting separation, carve-out, or New Co stand-up initiatives.
• Familiarity with regulated systems such as labeling, eIFU, or UDI.
• Prior experience acting as a central coordination or interdependency lead within a matrixed program.

Additional Requirements

• Local to the Raynham, MA area or able to be onsite as needed during the workweek.
• Comfortable working in an evolving environment with shifting priorities and timelines.

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