Senior Regulatory Affairs Specialist
Core
Prepare technical documents for regulatory submissions, maintain regulatory files and licenses across EU, US, and Canada, and manage post-market surveillance for medical devices.
Role type
Senior Regulatory Affairs Specialist (Medical Devices)
Builds
Regulatory submissions and compliance documentation for organ preservation and perfusion products
Domain
Medical Devices / Biologics / Organ Transplantation
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Regulatory submission authoring (US, Canada, EU), Gap analysis, Complaint assessment, Recall management, Post-market surveillance, Procedure development (ISO 13485, MDSAP), UDI listing management, Audit coordination
Preferred skills
None stated
Technologies
None stated
Responsibilities
Prepare technical documents for market-specific regulatory submissions; Maintain regulatory files and licenses in active jurisdictions; Assess device complaints and prepare reportable incident forms; Lead regulatory notices, recalls, and field actions; Participate in internal and external audits; Assess regulatory impact of product design changes; Oversee post-market surveillance activities
Seniority
Senior, hands-on IC