Projektleiter:in Regulatory Affairs – Medizinsoftware
Core
Leading cross-functional projects to achieve medical software certification under the MDR, coordinating between development, product management, and quality teams.
Role type
Senior Project Manager, Regulatory Affairs (Medical Software)
Builds
Certified medical software products
Domain
Medical Devices / Regulated Software
Deliverable
production ML models
Required skills
Project management, MDR compliance, stakeholder coordination, risk management, documentation management, budgeting, resource planning
Preferred skills
Medical device regulation experience, ISO 9001/13485/27001 knowledge, audit experience, AI tools proficiency
Technologies
AI tools
Responsibilities
Coordinate cross-functional teams for certification projects, manage MDR certification milestones and risks, maintain certification documentation, report to executive leadership, align regulatory and agile development processes
Seniority
Senior, hands-on IC
