Qa Ra Lead

## About the Role As a Ketryx QA/RA Lead, you will lead quality management system implementations and regulatory compliance strategies for cutting-edge medical device clients as we scale our AI-powered compliance platform. This is a rare opportunity to shape the future of regulatory affairs. You'll have the autonomy and expertise to drive repeatable QMS deployment processes while helping shape the future of regulatory affairs through innovative technology and enabling the success of the world's most innovative companies. We offer the opportunity to work with high-growth clients, establishing best-in-class quality systems from the ground up using our revolutionary AI platform. Our ideal candidate will have demonstrated success in quality systems management with 5-8 years of experience in the medical device industry. Someone who is strategic yet hands-on, passionate about regulatory excellence, and eager to leverage cutting-edge AI technology will thrive in this position. In this role, you'll have the opportunity to directly impact our mission to improve 100 million patient lives by 2030 by ensuring the highest quality standards for life-saving medical devices. ## Location and Schedule This position will be based in our Vienna, Austria office with a hybrid schedule (Monday, Wednesday, Friday in office, Thursday, Friday WFH option). Unfortunately, we are unable to support non-EU citizens for the position at this time. ## About You You're a proven QMS expert who's successfully navigated complex medical device regulatory landscapes and is ready to scale your impact through innovative technology. You've built or significantly improved quality systems at medical device companies, consulting firms, or high-growth startups, and you're excited to combine your regulatory expertise with AI-powered tools to create something category-defining. You are an energetic, creative, and progressive quality leader who thrives on driving innovation and continuous improvement in regulated environments. ## Responsibilities - Lead Quality Management System (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 - Develop repeatable QMS deployment processes leveraging AI platform capabilities and automatic compliance - Drive and/or support internal and external audit programs, customer audits and regulatory inspections - Orchestrate the continuous validation lifecycle, including drafting, reviewing, and approving documentation to ensure real-time compliance program management - Shape the future of regulatory affairs through innovative product development - Work independently on complex quality assurance projects requiring minimal oversight - Ensure customer success across the entire customer engagement lifecycle ## Required Skills - 4-8 years of experience in quality systems management, management representative or senior specialist role - Familiar with eQMS implementation, validation and implementation - Deep expertise in Quality Management System setup, sub-systems, and implementation - Strong knowledge of ISO 13485 and Global QMS requirements - Expertise in AI, Digital, SaMD and Cyber Compliance (e.g. SOC 2, ISO 27001) - Deep understanding of medical device cybersecurity - Experience as quality management representative in regulated environments - Proven experience managing audit lifecycles (internal, external, and customer-facing) - Familiarity with continuous validation methodologies (e.g. CSV, GAMP 5, ISO 13485) and documentation within a digital or automated compliance environment - Experience with regulatory and Notified Body submission requirements - Background in medical device industry quality systems - Ability to work independently and own complex regulatory projects - Proven track record in consulting or client-facing roles ## Preferred Skills - Experience at large medical device companies - Background with consulting firms specializing in QMS setup - Startup experience (Series A/B) with QMS implementation - Specializations in cybersecurity, usability, or computer software validation - Experience scaling quality operations in high-growth environments - Knowledge of AI applications in regulatory affairs - Submission experience - Experience working in an early stage, product-based start up ## Keywords ISO 13485, EU MDR/IVDR & UKCA, Quality Management System (QMS), Management representative, Medical device quality, Stryker, Medtronic, Boston Scientific, QMS setup, Regulatory consulting, Quality systems manager, Computer software validation, Cybersecurity, Usability, Startup experience, Series A/B, Vienna/Austria, Consulting firms, Quality assurance, Medical device industry