QA/RA Consultant

Ketryx

Vienna💼 Full-time💰 $90,000–$90,000🗓 2026-07-13 → 2026-09-26

Core

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

Role type

Senior IC QA/RA Consultant (Medical Device Regulatory Affairs)

Builds

Quality Management Systems (QMS) and regulatory compliance frameworks for medical device manufacturers

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, client consulting

Preferred skills

Large medical device company background, consulting firm experience, startup scaling, cybersecurity/usability validation, AI in regulatory affairs

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