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Job Title: QA/RA Lead
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.
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.
This position will be based in our Vienna, Austria office with a hybrid schedule (Monday, Wednesday, Friday in office, Thusday, Thursday 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:
Required Skills:
Preferred Skills:
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
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!
Ready to apply?
Apply to KetryxJob Title: QA/RA Consultant
Employment Status: Full-time
Office Hours: Monday - Friday; hybrid schedule
Location: Boston, Massachusetts
Compensation: $130,000 - $150,000, plus equity options. (Compensation dependent on experience level)
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 position will be based in our Boston, Massachusetts office with a hybrid schedule (Monday, Tuesday, Thursday, Friday in office, Wednesday WFH option). Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of employment Visas (including H-1B), F-1 visas, or Optional Practical Training (OPT) status at this time.
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.
Keywords: ISO 13485, MDSAP, 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, Boston/Massachusetts, 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!
Ready to apply?
Apply to KetryxJob Title: Delivery and Success Manager
Employment Status: Full-time
Office Hours: Monday - Friday; 4:1 hybrid schedule
Location: Boston, Massachusetts
Compensation: $90,000 - $115,000 base + variable + equity options
*compensation may be negotiated based on experience level
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.
Just two years since launch, Ketryx already touches the lives of 25M patients and powers 3 of the world’s top 5 MedTech companies and 25% of the Fortune 500 MedTech market. 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.
As a Delivery and Success Manager at Ketryx, you will lead strategic client engagements, guiding enterprise MedTech companies through onboarding and implementation. You’ll act as a trusted advisor, collaborating with regulatory and solutions experts to solve complex technical challenges and drive measurable business value.
This role is ideal for a self-starter who thrives in a fast-paced, high-growth environment and wants to make a direct impact on both clients and patient safety. You’ll have the autonomy to shape outcomes and grow your career as Ketryx continues to scale.
Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of employment Visas (including H-1B), F-1 visas, or Optional Practical Training (OPT) status at this time.
Client Leadership
Implementation Excellence
Technical & Quality Expertise
Team Leadership & Culture
Keywords: customer success, professional services, systems engineer, Solutions Architect, Software as a Medical Device, SaMD, product management, technology, client management, quality, regulatory, system engineer, B2B
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!
Ready to apply?
Apply to KetryxJob Title: Delivery and Success Associate - Enterprise
Employment Status: Full-time
Office Hours: Monday - Friday; hybrid schedule
Location: Boston, Massachusetts
Compensation: $62,000 - $75,000 base + variable + equity options
*compensation may be negotiated based on experience level
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.
Just two years since launch, Ketryx already touches the lives of 25M patients and powers 3 of the world’s top 5 MedTech companies and 25% of the Fortune 500 MedTech market. 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.
As a Delivery and Success Associate - Enterprise, you’ll work closely with customers who rely on Ketryx to manage safety‑critical and regulated development processes. This is a technical, engineering‑adjacent role.
You’ll support customers from onboarding through long‑term partnership, helping configure the Ketryx platform, supporting requirements and quality workflows, and applying structured problem solving to real challenges. You’ll develop a deep understanding of how regulated teams build, verify, and validate software.
This is an excellent opportunity for early‑career engineers or technically trained professionals who want exposure to regulated industries, verification & validation practices, and customer‑facing technical work, while growing alongside a mission‑driven team.
You bring an engineering mindset to your work. You like understanding how systems fit together, why processes exist, and how to improve them. You’re comfortable learning complex concepts and applying structure and logic to ambiguous problems.
You’re excited by the opportunity to work close to engineering, quality, and regulated product development, while also collaborating directly with customers.
You’re curious, detail‑oriented, and motivated by meaningful work that has real‑world impact.
Keywords: customer success, client operations, delivery and success, professional services, systems engineer, Solutions Architect, Software as a Medical Device, SaMD, product management, technology, client management, quality, regulatory, system engineer, B2B, regulation, task management, project management, Greater Boston, MA, SQL, KQL, python, java
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!
Ready to apply?
Apply to KetryxCookies & analytics
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