QA/RA Consultant

This is a full-time position based in our Vienna, Austria office, with a hybrid 💼 Full-time💰 $90,000–$90,000🗓 2026-09-26

Core

Lead QMS setup, deployment, and regulatory compliance strategies for medical device clients using an AI-powered platform.

Role type

Senior QA/RA Consultant (Medical Device)

Builds

Repeatable QMS deployment processes and compliance frameworks for regulated industries

Domain

Healthcare life sciences / Medical Devices / Regulatory Affairs

Deliverable

production ML models | product features | dashboards & analysis | client delivery

Required skills

QMS setup and implementation, ISO 13485, EU MDR/IVDR, UKCA, GxP, audit lifecycle management, continuous validation (CSV, GAMP 5), medical device cybersecurity, consulting/client-facing experience

Preferred skills

Experience at large medical device companies, consulting firm background, startup experience (Series A/B), cybersecurity or software validation specialization, AI in regulatory affairs

Technologies

AI-powered compliance platforms, eQMS tools

Responsibilities

Lead QMS setup and deployment for medical device clients, Own and manage QMS templates and regulatory compliance frameworks, Provide expert consulting on ISO 13485, EU MDR/IVDR, UKCA, GxP, and other quality systems standards, Scale operations to support high-growth clients, Drive and/or support internal and external audit programs, Orchestrate the continuous validation lifecycle

Seniority

Senior, hands-on IC with strategic consulting scope

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