Sr. Associate, Lifecycle Management
Core
Manage regulatory affairs activities and product lifecycle management to ensure compliance with global and local regulations for medical products.
Role type
Senior Associate, Lifecycle Management (Regulatory & Quality)
Builds
Regulatory submissions, product change requests, and compliance documentation for medical devices.
Domain
Medical Devices / Regulatory Affairs / Quality Management
Required skills
Regulatory compliance, lifecycle management, change control, data analysis, ERP systems, project management, documentation management
Preferred skills
SAP ERP, BI reporting tools, manufacturing operations, supply chain processes, change control systems
Technologies
SAP, Ensure, TrackWise, Alcon ERP
Responsibilities
Prepare and submit regulatory documents, lead New Product Launch and Product Change Request projects, manage packaging component changes, coordinate material master setup and change requests, monitor change control records, collaborate cross-functionally with Manufacturing, Supply Chain, and Quality teams.
Seniority
Senior, hands-on IC