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Wien, Österreich
Hybrid
Not Available
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 tradeoff 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). Ideally you're already located in Vienna or able to relocate quickly. Unfortunately, we are unable to support people without an existing work permit for this position in Austria 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:
Required Skills:
Preferred Skills:
Keywords: ISO 13485, EU MDR/IVDR & UKCA, Quality Management System (QMS), Management representative, Medical device quality, 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
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
Ketryx is saving and improving lives by making medical software safe and reliable. We empower software teams building medical applications to create safe, secure, and compliant products used by patients and providers worldwide. We believe that, by automating much of the documentation and quality processes, teams will be able to produce safer and more innovative medical software faster.
Ketryx is at the forefront of helping teams incorporate AI/ML into medical software and that’s why we need you!
