Regulatory & Quality Manager
Core
Transform complex regulatory requirements into practical, scalable solutions to support the development and certification of AI medical devices.
Role type
Regulatory & Quality Manager
Builds
AI-powered medical devices
Domain
Medical devices / AI / Regulatory Affairs
Deliverable
production ML models
Required skills
Regulatory Affairs (EU MDR), ISO 13485 QMS management, Technical documentation preparation, Notified Body interaction, Risk management, Analytical thinking
Preferred skills
Digital health, AI, Innovative medical technologies
Technologies
ISO 13485, EU MDR
Responsibilities
Own and continuously improve the ISO 13485-certified Quality Management System; Lead MDR conformity assessments and interactions with Notified Body; Prepare technical documentation for AI-powered medical devices; Act as the regulatory partner for interdisciplinary product teams; Support audits, risk management, and continuous improvement activities.
Seniority
Mid-Senior, hands-on IC