Head of QARA
Core
Define global regulatory strategy and ensure AI-native radiology solutions meet safety standards for MDR/FDA market entry.
Role type
Head of Quality, Regulatory Affairs, and Risk Assessment (QARA)
Builds
AI-native medical devices for radiology (SaMD)
Domain
Medical device regulation, AI in healthcare, radiology
Deliverable
client delivery
Required skills
Medical device regulations (MDR, FDA), Quality Management Systems (ISO 13485), regulatory submissions, risk management, software standards, mentoring junior staff
Preferred skills
AI/ML specific regulations (AI Act, FDA AI frameworks), start-up experience, radiology workflows
Technologies
None stated
Responsibilities
Lead global regulatory strategy (MDR, FDA), manage submission process and coordinate technical files, maintain and improve QMS, act as main contact for Notified Bodies and authorities, partner with R&D and Product teams for Compliance by Design
Seniority
Senior, hands-on IC with mentorship
