AtBloodFlow, we're building an AI platform that interprets blood test results in their full clinical context — helping doctors make faster, safer, and more informed decisions.
We combineLLMs,RAG pipelines, andmedical best practicesto transform raw lab data into structured, actionable insights.
Our solution is already being used by clinics and hospitals, and we're preparing for our firstregulatory certificationsandCE marking as a Class IIa medical device.
Role Summary
We're looking for aHead of Qualityto lead BloodFlow's regulatory and quality journey.
You'll work directly with the founder to design and implement the systems that ensure our compliance with European healthcare and data protection standards.
You will be responsible for building our regulatory processes and helping the company navigate audits, certifications, and interactions with regulatory bodies (Infarmed, EMA, etc.).
Certifications & Standards in Roadmap
ISO 13485 – Quality Management for Medical Devices
ISO 27001 – Information Security Management
ISO 14971 – Risk Management for Medical Devices
GDPR – General Data Protection Regulation (EU)
Responsibilities
Build and maintain our QMS (Quality Management System)
Own regulatory compliance strategy for medical software
Lead certification processes (ISO 13485, 27001, 14971, GDPR)
Collaborate with tech and clinical teams to align with standards
Manage internal audits and prepare for external inspections
Liaise with regulatory authorities (Infarmed, EMA, etc.)
What We're Looking For
5+ years in regulatory/quality roles in medtech or healthtech
Experience leading ISO and GDPR certification processes
Strong understanding of SaMD (Software as a Medical Device)
Excellent written/verbal communication in English (Portuguese a plus)
Proactive, hands-on, and comfortable in early-stage environments
What We Offer
Salary Range
Competitive
Leadership position in a growing healthcare AI company
Direct impact on company strategy and regulatory approach
Opportunity to establish best-in-class quality processes from the ground up
Work with cutting-edge AI technology in a regulated environment
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