The medical device industry is rapidly embracing AI-powered compliance and digital quality management systems, creating exciting career opportunities for experienced Quality Assurance and Regulatory Affairs professionals. If you’re looking to take your QA/RA career to the next level in Europe, Ketryx is hiring an experienced QA/RA Consultant for its Vienna, Austria office.
This is an outstanding opportunity for professionals with 4โ8 years of experience in Quality Management Systems (QMS), ISO 13485, Medical Device Regulations, Regulatory Affairs, and Compliance to work with innovative MedTech companies while leveraging cutting-edge AI technology.
If you’re passionate about medical device quality, regulatory excellence, and digital transformation, this could be your dream opportunity.
๐ Job Overview
Company: Ketryx
Position: QA/RA Consultant
Location: Vienna, Austria
Work Mode: Hybrid (Office: Monday, Wednesday, Friday | WFH: Tuesday & Thursday)
Employment Type: Full-Time
Experience Required: 4โ8 Years
Industry: Medical Devices | Healthcare Technology | Regulatory Compliance
Salary: Starting from โฌ90,000 Gross Base Salary + Bonus + Equity
Eligibility: EU Citizens (No Visa Sponsorship Available)
๐ข About Ketryx
Ketryx is one of the fastest-growing healthcare technology companies transforming regulatory compliance using Artificial Intelligence. Their AI-powered compliance platform enables medical device companies to automate documentation, streamline regulatory workflows, simplify audits, and maintain continuous compliance throughout product development.
The company works with innovative MedTech startups and global healthcare organizations to accelerate regulatory approvals while ensuring the highest standards of patient safety.
Ketryx has a bold mission:
Improve 100 million patient lives by 2030 by making regulatory compliance faster, smarter, and AI-driven.
Their platform combines:
- ๐ค Artificial Intelligence
- ๐ฉบ Medical Device Compliance
- ๐ Quality Management Systems
- ๐ Cybersecurity Compliance
- โ๏ธ Cloud-Based Regulatory Solutions
Working at Ketryx means contributing to healthcare innovation while solving real-world regulatory challenges.
โญ Why This Role is Great for Experienced Professionals
This role is ideal for QA and Regulatory professionals who want to move beyond routine compliance activities and become strategic consultants.
Some key benefits include:
- ๐ฐ Attractive salary starting from โฌ90,000 annually
- ๐ฏ Performance bonus and equity options
- ๐ Hybrid work model
- ๐ Opportunity to work with AI-powered compliance technologies
- ๐ Exposure to global medical device regulations
- ๐ Leadership opportunities with high-growth MedTech clients
- ๐ค Client-facing consulting experience
- ๐ง Opportunity to shape future regulatory technologies
- ๐ Continuous learning in AI, Digital Health, and SaMD
- โค๏ธ Direct contribution toward improving patient safety worldwide
If you enjoy solving complex regulatory challenges while working with innovative technologies, this role offers excellent long-term career growth.
๐ผ Roles & Responsibilities
As a QA/RA Consultant, you’ll work directly with medical device companies to establish and improve quality systems.
Your responsibilities include:
- โ Lead Quality Management System (QMS) implementations
- โ Design regulatory compliance strategies
- โ Manage ISO 13485 implementation
- โ Guide clients through MDR, IVDR, UKCA, and GxP compliance
- โ Develop scalable compliance frameworks
- โ Create repeatable AI-driven QMS deployment processes
- โ Conduct internal, customer, and regulatory audits
- โ Manage validation documentation
- โ Ensure continuous regulatory compliance
- โ Support regulatory inspections
- โ Collaborate with product teams
- โ Drive customer success initiatives
- โ Shape next-generation AI compliance products
๐ Skills Required
Ketryx is looking for experienced professionals with expertise in:
Mandatory Skills
- ISO 13485
- Medical Device Quality Management Systems
- EU MDR
- IVDR
- UKCA
- GxP
- eQMS Implementation
- Regulatory Compliance
- Internal Audits
- Customer Audits
- Risk Management
- Continuous Validation
- Medical Device Documentation
- AI Compliance
- Digital Health
- Cybersecurity Compliance
- CSV
- GAMP 5
- Client Consulting
Preferred Skills
- AI Regulatory Platforms
- SaMD
- SOC 2
- ISO 27001
- Startup Experience
- Medical Device Cybersecurity
- Product Validation
- Regulatory Submission Experience
- High-growth MedTech environments
๐ถ Expected Salary Range
Although compensation depends on experience and negotiation, the expected package is highly competitive.
| Experience | Expected Salary |
|---|---|
| 4โ5 Years | โฌ90,000 โ โฌ100,000 |
| 6โ8 Years | โฌ100,000 โ โฌ120,000+ |
| Additional benefits may include: |
- ๐ฐ Performance Bonus
- ๐ Equity Options
- ๐ฅ Healthcare Benefits
- ๐ก Hybrid Work
- ๐ Learning Programs
- ๐ International Exposure
๐ Expected Interview Rounds
Candidates can generally expect the following recruitment process:
Round 1 โ HR Screening
- Experience discussion
- Motivation
- Salary expectations
- Eligibility verification
Round 2 โ Technical Interview
Topics may include:
- ISO 13485
- QMS Architecture
- MDR & IVDR
- Risk Management
- Validation
- Audit Experience
- CAPA
- Design Controls
Round 3 โ Scenario-Based Interview
Real client consulting situations involving:
- Regulatory strategy
- Compliance planning
- Audit preparation
- AI implementation
Round 4 โ Leadership Interview
Focus areas include:
- Client management
- Problem solving
- Stakeholder communication
- Team collaboration
Final Round
Offer discussion and onboarding.
๐ฏ Preparation Tips
To maximize your chances of selection:
- ๐ Review ISO 13485 thoroughly
- ๐ Understand EU MDR and IVDR requirements
- ๐ Prepare CAPA and Risk Management examples
- ๐ Learn Design Controls
- ๐ Understand GAMP 5
- ๐ Review Computer System Validation
- ๐ Study AI in Regulatory Affairs
- ๐ Practice audit-related questions
- ๐ Revise cybersecurity regulations
- ๐ Prepare examples of successful QMS implementations
- ๐ Brush up on client consulting experiences
๐ Resume Tips
A strong QA/RA resume should include:
- Highlight QMS implementation experience
- Mention ISO certifications
- Include audit experience
- Showcase regulatory submissions
- Mention AI or digital compliance exposure
- Quantify achievements
- Include client-facing consulting work
- Highlight leadership experience
- Keep resume within 2 pages
- Tailor the resume for medical device compliance
๐ Why You Should Consider Ketryx
Ketryx is not just another MedTech company. It is building the future of AI-powered regulatory compliance.
Reasons to join:
- ๐ Fast-growing startup
- ๐ค AI-powered healthcare platform
- ๐ International projects
- ๐ Career acceleration
- ๐ผ High salary package
- ๐ง Cutting-edge technology
- โค๏ธ Purpose-driven mission
- ๐ฅ Real impact on patient lives
๐ฉ How to Apply
๐ Application Link: Click Here
Position: QA/RA Consultant
Location: Vienna, Austria
You should prepare:
- Updated Resume
- Cover Letter (Optional but Recommended)
- Relevant Certifications
- Regulatory Project Experience
- ISO/QMS Achievements
- Client Consulting Experience
If you’re an experienced Quality Assurance or Regulatory Affairs professional looking to work on AI-powered compliance solutions while earning an excellent European salary, the Ketryx QA/RA Consultant role is definitely worth exploring. It combines regulatory expertise, consulting, artificial intelligence, and healthcare innovation into one rewarding career opportunity.
