Sr. Project Coordinator, Medical Device

Role

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.

• 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.

• 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.

• 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.

• 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.