Lead Systems Engineer - Registration Documentation (Healthcare/medical devices)
Core
Primary R&D interface to International Registrations, coordinating and maintaining technical documentation for global medical device regulatory registrations and market access.
Role type
Lead Systems Engineer (Registration Documentation)
Builds
Global regulatory documentation libraries and submission packages for medical devices
Domain
Medical devices / Life sciences / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Medical device regulatory frameworks (MDR, IVDR, FDA), Product lifecycle documentation, Risk management, Verification and validation, Controlled documentation systems management, Technical documentation interpretation
Preferred skills
IVD product registration, Cross-functional R&D/Regulatory collaboration, SharePoint information management
Responsibilities
Act as primary contact between International Registrations and R&D for technical documentation; Maintain and improve the documentation library for international registration; Identify and collect documentation for registrations and renewals; Collaborate with Regulatory Affairs and Product Development to ensure documentation accuracy; Manage UDI data and documentation retrieval
Seniority
Senior, hands-on IC