Head Of Quality Lisboa

Head Of Quality
Lisboa
Lisboa, Lisboa, Portugal

At Blood
Flow, 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 combine LLMs, RAG pipelines, and medical best practices to transform raw lab data into structured, actionable insights. Our solution is already being used by clinics and hospitals, and we're preparing for our first regulatory certifications and CE marking as a Class IIa medical device.

Role Summary

We're looking for a Head of Quality to lead Blood
Flow'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 Sa
  MD (Software as a Medical Device)
• Excellent written/verbal communication in English (Portuguese a plus)
• Proactive,
  - on, and comfortable in
  - 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
-
- class quality processes from the ground up

Work with
- edge AI technology in a regulated environment

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