The Senior Specialist, Operations (Project Management) supports the Durham manufacturing site as a project leader and governance partner, leading complex high-visibility initiatives and establishing governance, reporting, for business objectives.
Compensation
$96,200.00 - $151,400.00
Responsibilities
Coordinate cross-functional Pre-Approval Inspection (PAI) and filing-readiness plans
Maintain integrated readiness trackers and dashboards for critical milestones and risks
Facilitate readiness reviews, working sessions, and governance updates
Manage the functional project portfolio including inventory of projects, priorities, resource needs, and risks
Lead portfolio intake, prioritization, and sequencing processes
Supports the Durham manufacturing site as a project leader and governance partner, leading complex initiatives and coordinating cross‑functional teams to achieve inspection readiness and operational excellence.
Compensation
The salary range for the primary location of this role is: $96,200.00 - $151,400.00
Responsibilities
Coordinate cross‑functional PAI and filing‑readiness plans
Maintain integrated readiness trackers and dashboards
Facilitate readiness reviews and governance updates
Partner with subject matter experts on filing documents
Identify and mitigate schedule or compliance risks
Requirements
Bachelor’s degree in Engineering, Science, Business, Project Management, or a related field
Project Management Professional (PMP) certification
Lead medical-device market expansion projects, including product entry, registration, and launch readiness coordination.
Responsibilities
Lead end-to-end planning and execution of medical-device market expansion projects, from project initiation and market-specific gap assessment through registration and launch readiness.
Develop and maintain an integrated project plan covering regulatory strategy and submissions, technical documentation, clinical evidence, labeling and localization, manufacturing and supply readiness, and commercial launch dependencies.
Coordinate market-specific documentation gap assessments with Regulatory Affairs, Quality, R&D, Clinical Affairs, and Medical Affairs.
Manage schedules, resources, budget forecasts, and critical-path dependencies; maintain risks, assumptions, issues, and dependencies logs and escalate constraints with mitigation options.
Facilitate cross-functional working meetings and governance reviews; communicate status, decisions, and actions.
Lead end-to-end planning and execution of medical-device market expansion projects, from project initiation and market-specific gap assessment through registration and launch readiness.
Locations (3)
West Chester, Pennsylvania, United States
Raynham, Massachusetts, United States
Warsaw, Indiana, United States
Responsibilities
Lead end-to-end planning and execution of medical-device market expansion projects, from project initiation and market-specific gap assessment through registration and launch readiness.
Develop and maintain an integrated project plan covering regulatory strategy and submissions, documentation, clinical evidence, labeling and localization, manufacturing and supply readiness, and commercial launch dependencies.
Coordinate market-specific documentation gap assessments with Regulatory Affairs, Quality, R&D, Clinical Affairs, and Medical Affairs.
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