Better breast cancer screening should be a universal offering to every woman in the world. Vara’s AI-powered software platform, created with screening radiologists in Germany, mitigates much of the human subjectivity associated with reading mammography results—and reduces the repetitive work screening physicians are routinely subjected to—we’re making breast cancer screening more effective, more measurable, and more accessible for everyone, everywhere. By democratizing access to early screening around the world, we deliver measurable impact backed by clinical evidence. We are partnering globally, to deliver breast cancer screening where it is needed most.
As the first company from Europe’s leading AI venture studio Merantix, Vara has grown since 2018 to become a 50-member international team. Our diverse team consists of highly motivated and ambitious entrepreneurs, healthcare professionals, and technology experts.
Further information can be found on our website: www.vara.ai

Your role

As the Team Lead Quality & Regulatory Affairs, you will be responsible for developing and executing regulatory strategies on a global scale while overseeing and maintaining the quality management system (QMS) in compliance with ISO 13485. You will ensure that all products meet applicable regulatory requirements and company standards, manage internal and external audits, and drive continuous improvement initiatives within the organization. Additionally, you will advise on data protection obligations, monitor compliance, and act as a point of contact for data subjects and supervisory authorities.

Key Responsibilities:

Regulatory Strategy
- Develop and implement comprehensive regulatory strategies aligned with business objectives and market access plans.
- Oversee the preparation, submission, and maintenance of regulatory filings globally.
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.
Audits and Compliance
- Manage internal and external audits to ensure compliance with regulatory requirements.
- Drive continuous improvement initiatives within the organization.
Data Protection
- Monitor and develop the organization’s data processing strategies to ensure compliance with GDPR and other applicable data protection laws.
- Provide training and support to staff on data protection obligations and best practices.
Stakeholder Engagement
- Act as the 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:

Bachelor’s degree or higher in a relevant field (e.g., Engineering, Life Sciences, Quality Management).
Minimum of 5 years of experience in the management of QMS within the medical device industry, with a strong understanding of ISO 13485.
Proven leadership experience with strong decision-making capabilities.
Extensive knowledge of global regulatory requirements and submission processes.
Excellent communication, negotiation, and interpersonal skills.
Strategic thinking and problem-solving abilities.
High attention to detail and accuracy.
Flexibility and adaptability to work in a fast-paced, dynamic environment with changing market conditions.

Nice to have:

Experience with applicable Data Privacy Laws is a plus.
Experience with medical device software and ISO 27001 is desirable.
Internal Auditor certification is highly desirable.

What we offer

Work flexibly
In-office? From home? Somewhere in between? Whatever you prefer.
Team Culture
We host regular team nights and events to foster company culture and cohesion.
Connect at our AI Campus
Meet some truly exceptional humans at the AI campus — home to countless inspiring startups, events, and opportunities to broaden your horizons.
Competitive salary
We regularly benchmark salaries within the tech and healthcare industry.
Develop your career
Dedicate yourself to impactful projects and have regular, meaningful career development sessions with your manager.

Apply for this job

About us

We are an equal-opportunity employer that values diversity. We consider all applications equally, regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity. We strongly encourage individuals from groups that are traditionally underrepresented in tech to apply.
Additionally, we provide immigration assistance for those who need it.

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