AI-Powered QA/RA Consultant - Med Device QMS Lead

Transformcap; Wien; Hybrid; EUR 81.000 - 99.000; Vollzeit

Benefits dieser Stelle

Competitive compensation

Stock options possible

Generous PTO

Zusammenfassung

Ketryx in Vienna, Austria is seeking a QA/RA Consultant to lead Quality Management System implementations and regulatory compliance strategies for medical device clients using our AI-powered platform.

The ideal candidate will have 4–8 years in quality systems, deep ISO 13485 knowledge, and a strategic yet hands‑on approach to regulatory excellence. This full‑time hybrid role features office days Monday, Wednesday, Friday with optional remote Tue/Thu.

Qualifikationen

• 4–8 years of experience in quality systems management or senior specialist roles.
• 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.

Aufgaben

• 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

Kenntnisse

Quality management

QMS deployment

ISO 13485

GxP/compliance

AI in regulatory

Cybersecurity compliance

Auditing

Independent work

Tools

eQMS

Jobbeschreibung

Ketryx in Vienna, Austria is seeking a QA/RA Consultant to lead Quality Management System implementations and regulatory compliance strategies for medical device clients using our AI-powered platform.

The ideal candidate will have 4–8 years in quality systems, deep ISO 13485 knowledge, and a strategic yet hands‑on approach to regulatory excellence. This full‑time hybrid role features office days Monday, Wednesday, Friday with optional remote Tue/Thu.