Quality Manager in Regulatory Affairs (f/m/d)
Posted on January 21, 2026 (about 3 hours ago)
What we do
At Vara, we believe better breast cancer detection should be a standard offering for every woman, everywhere. Our AI-powered software platform, developed in close collaboration with radiologists in Germany, leads to higher cancer detection, lower false positive rate and alleviates the repetitive workload involved in routine screening — proven in the largest prospective study in healthcare to date with around 500,000 participating women.
Our mission is to make breast cancer screening more effective, measurable, and accessible. By enhancing early detection and ensuring outcomes backed by clinical evidence, we’re proud to contribute to national efforts focused on improving women’s health.
Founded in 2018 as the first company to emerge from Europe’s leading AI venture studio, Merantix, Vara has grown into an international team of 25 driven professionals. Our diverse team brings together entrepreneurs, healthcare experts, and technology innovators united by a common goal: transforming breast cancer screening for the better.
Further information can be found on our website: www.vara.ai
Your role
As Quality Manager in Regulatory Affairs, you will be responsible for maintaining and continuously improving the company’s Quality Management System (QMS), ensuring compliance with ISO 13485 and applicable regulatory requirements. You will coordinate updates to key SOPs and processes, support internal audits, data privacy, and IT security, and act as the person responsible for regulatory compliance in accordance with MDR. You will also provide guidance and support to employees and stakeholders on quality and compliance issues.
Key responsibilities include:
- Lead and maintain the QMS in accordance with ISO 13485 standards, and act as the person responsible for regulatory compliance.
- Provide training and support to staff on QMS processes, regulatory requirements, and best practices; prepare for management reviews and support SOP management.
- Manage internal and external audits to ensure compliance and drive continuous improvement initiatives.
- Support IT security and related employee training activities connected to the QMS.
- Act as an in-house quality and regulatory expert, advising and supporting internal and external stakeholders and collaborating with cross-functional teams across the product lifecycle.
Your profile
Requirements:
- Higher education degree (PhD, BA, MA) and at least two years of experience managing quality management systems.
- Strong communication skills in English and German.
- Proven experience in Quality Management within the medical device industry, preferably in SaMD/AIaMD (4+ years).
- Strong knowledge of QMS, CAPA, Management Reviews, and risk management (especially ISO 14971).
- Familiarity with AI/ML validation, software development workflows, and lifecycle management.
- Experience with regulatory submissions and audits (MDR, IVDR, MDSAP, FDA SaMD Guidance, IMDRF).
Nice to have:
- Certified Auditor for ISO 13485 (additional ISO 27001, ISO 9001 a plus).
- Experience in cybersecurity, data privacy (GDPR, HIPAA, IEC 81001, IEC 27001).
- Understanding of AI/ML-specific regulatory requirements (e.g., GMLP, EU AI Act).
- Prior experience in startup or scale-up environments.
- Fluent in German (minimum B2-level).
What we offer
Flexible work & team spirit: Whether from home or at our Berlin office, you are free to shape your workday. The company fosters team spirit through regular get-togethers, offsites, and team events.
Fair & competitive compensation: Salaries are regularly benchmarked within the tech and healthcare sectors to ensure recognition and fair reward.
Work at the Merantix AI Campus: Join the Merantix AI Campus in Berlin to connect with inspiring people and innovative startups within a creative and knowledge-sharing community.
Your growth, our priority: Personal and professional development is supported through regular development talks and opportunities to work on exciting projects.
About us
We stand for an open, diverse working environment and are actively committed to equal opportunities. We especially encourage applicants from groups underrepresented in the tech industry. We are also happy to support candidates with immigration and visa processes.
Your application
Thank you for considering a career at Vara. Please fill out the application form on this page to apply. If you experience problems with the document upload, please send your documents by email to [email protected].
Data privacy
A data privacy statement is available on the company's site. Please review it before submitting your application.