QA & RA Officer
Core
Ensuring Nicolab's quality management system and product registrations comply with international medical device regulations (ISO 13485, EU MDR, FDA QMSR) to enable safe AI-powered stroke imaging software deployment.
Role type
Quality & Regulatory Affairs Officer (Medical Device)
Builds
Compliant medical device software products for stroke imaging in international markets
Domain
Medical Device / AI Software / Healthcare Technology
Deliverable
production ML models
Required skills
ISO 13485, EU MDR, FDA QMSR, technical file management, audit preparation, CAPA, post-market surveillance, regulatory change monitoring
Preferred skills
SaMD, AI-based products, IEC 62304, ISO 14971, IEC 62366
Technologies
ISO 13485, EU MDR, FDA QMSR, IEC 62304, ISO 14971, IEC 62366
Responsibilities
Write and maintain technical files for products; keep QMS up to date by drafting procedures and managing document control; prepare and run internal and external audits; support product registrations and renewals; monitor regulatory changes; support post-market surveillance and complaint handling; train colleagues and partners on quality and regulatory topics.
Seniority
Mid-level, hands-on IC