Ketryx QA/RA Consultant Vienna Austria

Ketryx is hiring an experienced QA/RA Consultant for its Vienna, Austria office. This role offers an opportunity for professionals with 4-8 years of experience in Quality Management Systems, ISO 13485, Medical Device Regulations, Regulatory Affairs, and Compliance to work with innovative MedTech companies while leveraging cutting-edge AI technology. The company is transforming regulatory compliance using Artificial Intelligence and has a mission to improve 100 million patient lives by 2030.

Lead Quality Management System (QMS) implementations, Design regulatory compliance strategies, Manage ISO 13485 implementation, Guide clients through MDR, IVDR, UKCA, and GxP compliance, Develop scalable compliance frameworks, Create repeatable AI-driven QMS deployment processes, Conduct internal, customer, and regulatory audits, Manage validation documentation, Ensure continuous regulatory compliance, Support regulatory inspections, Collaborate with product teams, Drive customer success initiatives, Shape next-generation AI compliance products

4-8 years experience in Quality Management Systems, ISO 13485, Medical Device Regulations, Regulatory Affairs, and Compliance. EU Citizenship required (No Visa Sponsorship Available).