QA/RA Lead

• →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

• 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

• 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