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 workstreams. 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 workstreams.
- 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 NewCo 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 workstreams and functional deliverables are clearly understood and documented.
- Support the development, alignment, and tracking of procedures required for system separation and NewCo 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 NewCo 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 workstreams and functions.
- Excellent communication skills, with the confidence to engage across levels of the organization.
Preferred Qualifications- Experience supporting separation, carve-out, or NewCo 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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