Director, PRD Implementation & Change Management
Core
Global leader for Product Review Discipline (PRD) and Product Lifecycle processes, ensuring compliant, efficient, and user-centered design and development across GE HealthCare's enterprise.
Role type
Director, Process & Change Management
Builds
Global PRD and Product Lifecycle processes, tools, and learning systems for medical device product development.
Domain
Medical Technology / Regulatory Compliance / Product Lifecycle Management
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Program Management, Product Lifecycle Management, Change Management, Process Design, Continuous Improvement, Regulatory Compliance, Cross-functional Leadership, Strategic Planning, Risk Management, Stakeholder Engagement
Preferred skills
Engineering or Science degree, Design Controls expertise, Risk Management (ISO 13485, 21 CFR 820), NPI experience, Crisis Management, Team Coaching
Technologies
Change Acceleration Process (CAP), ISO 13485, US 21 CFR 820
Responsibilities
Drive global PRD and Product Lifecycle processes and enterprise learning strategy; Ensure processes support user-centered, compliant, and efficient design; Collaborate across SBUs to deliver high-priority changes; Define and implement global procedures and work instructions; Provide global messaging and enforce process metrics; Lead improvements from Idea through End of Product Life; Engage end users in decision making and iterative refinements; Monitor regulatory trends and represent the company with regulators; Coach and develop team members; Support regulatory inspections and inquiries.
Seniority
Director, strategic leadership & enterprise-wide process ownership
