QA/RA Consultant

Transformcap; Wien; Vor Ort; 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

Job Title: QA/RA Consultant
Employment Status: Full-time
Office Hours: Mon, Wed, Fri with WFH option on Tue & Thu
Location: Vienna, Austria
Compensation: Starting from 90,000 EUR gross base salary + performance-based bonus and equity options. Compensation may be negotiated based on experience level.

About Ketryx

Ketryx is an AI software platform that enables healthcare life sciences companies to ship life‑saving regulated products in weeks instead of years.

Exploding product complexity is burying companies in compliance paperwork and blocking innovation. Our AI software removes this friction, dissolving the historical trade‑off between innovation and compliance, and enables regulated industries to innovate at the pace of modern software.

Since launch, Ketryx already touches the lives of 100M patients and powers all of the world's top five medical device manufacturers. Backed by Lightspeed Ventures, our founders are the former Head of AI at Amgen and CTO of Wolfram Cloud.

Healthcare and life sciences is just the beginning for us. Automotive, aerospace, energy — if it's regulated, it's because society decided it matters. These products move humanity, shape our future, and are safety‑critical. Come join us and help build the AI platform to power safe innovation.

Job Summary

As a Ketryx QA/RA Consultant, 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.

This is a full‑time position based in our Vienna, Austria office, with a hybrid schedule (Monday, Wednesday, and Friday in the office; Tuesday and Thursday are optional work‑from‑home days). Unfortunately, we are unable to support non‑EU citizens for this position at this time, and we do not offer B2B contracts.

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

What We Offer

• Competitive compensation
• Generous stock options possible
• Work in an exciting field with a positive impact on the world
• Opportunity to learn and grow as part of a global team
• Generous PTO for full‑time

Ketryx is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sex (including pregnancy), sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances