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Senior Regulatory Affairs Specialist Medical Devices
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Quality Manager in Regulatory Affairs
vor 2 Stunden
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 ~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: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
Quality Management System (QMS)
Lead and maintain the QMS in accordance with ISO 13485 standards.
Ensure safety and compliance of our QMS processes 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 process owners in SOP management
Audits and Compliance
Manage internal and external audits to ensure compliance with regulatory requirements.
Drive continuous improvement initiatives within the organization.
IT Security
Support IT security and employee training activities related to the QMS
Stakeholder Engagement
Act as an in-house quality and regulatory expert, advising and supporting internal and external stakeholders.
Collaborate with cross-functional teams to ensure regulatory and quality compliance throughout the product lifecycle.
Your profile
Requirements:
Higher education degree (PhD, BA, MA) and two years of experience managing quality management systems
Strong communication skills (EN/DE)
Proven experience in Quality Management within medical device industry, preferably in SaMD/AIaMD (4+ years)
Strong knowledge of QMS, CAPA, Management Reviews, and risk management (esp. 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 additional ISO 27001, ISO 9001 as 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're free to shape your workday in the way that suits you best. We believe the best ideas come from collaboration, which is why we actively foster team spirit through regular get-togethers, offsites, and team events.
Work at the Merantix AI CampusJoin us at the Merantix AI Campus – the heart of Berlin's AI scene. Connect with inspiring people, innovative startups, and be part of a community that thrives on creativity and knowledge-sharing.
Fair & Competitive CompensationWe regularly benchmark salaries within the tech and healthcare sectors to ensure that your work is recognized and fairly rewarded.
A Range of Benefits That Fit Your LifeEnjoy monthly perks tailored to your needs – from Urban Sports Club subsidies to over 100 discounts across health, fitness, retail, and travel. Choose the benefits that support and motivate you the most.
Your Growth, Our PriorityYour personal and professional development matters to us. You'll work on exciting projects and have regular development talks with your leads to help shape your career path and reach your goals.
About us
We stand for an open, diverse working environment and are actively committed to equal opportunities. We welcome all applications, regardless of ethnic origin, skin colour, religion, gender, sexual orientation, age, nationality, marital status, disability or gender identity.
We especially encourage people from groups that are underrepresented in the tech industry to apply.
We are also happy to support you throughout the immigration and visa application process.
