Quality Manager – Clinical AI (w/m/d)

About Us

StratifAI is an innovative Berlin-based precision oncology startup developing the next generation of AI-based cancer biomarkers. The founders have published over 100 articles in top-tier journals and founded StratifAI to translate these novel ideas into patient care.

Our products enable cancer patients to receive the right treatment at the right time – both for existing drugs on the market, and by supporting pharmaceutical companies in developing the drugs of tomorrow.

Job Description

What We Offer

• The opportunity to make a real difference for cancer patients.
• Competitive salary, stock options and extra benefits.
• A beautiful office near Alexanderplatz with an on-site gym, private showers, free drinks and snacks, rooftop bar, co-working space, and a quiet room for meditation or prayer.
• Competing at the global top-tier of cancer research together with the founders, who are renowned researchers in the field of AI for biomarker development from medical imaging.
• An extremely fast-paced and high-growth VC-funded start-up environment with key ownership from day 1.

Our Core Values:

1. Trust, honesty & open communication between everyone
2. Saving time >>> money. Moving fast, 80/20 principle
3. Mistakes are ok as long as we learn from them, fast
4. We aim to be the best and deliver the highest quality, without egos

Job Key Responsibilities

• Develop and maintain an eQMS in compliance with ISO 13485.
• Lead the CE-IVDR certification process of our biomarkers.
• Work closely with the development team to ensure regulatory compliance during the AI product lifecycle.
• Prepare and manage technical documentation for regulatory submissions.
• Conduct internal audits and ensure readiness for external regulatory audits.
• Stay updated on global regulatory changes and provide recommendations to ensure compliance.
• Organize and conduct internal workshops to pass on regulatory knowledge to the team.
• Collaborate with our founders, consultants and advisory board members to shape our regulatory strategy.

Qualification & Skills

• You’re a strategic thinker that supports our go-to market strategy with your knowledge of regulatory pathways in the EU and US.
• Proven ability to develop, implement, and maintain QMS for medical devices.
• Experience with obtaining ISO13485 and CE-IVDR certification.
• Strong organizational and communication skills to collaborate across teams.
• Ability to write clear, concise technical documentation for regulatory submissions.
• Comfortable working independently in a fast-paced, startup environment.
• You’re a rapid learner who knows how to effectively explore and utilize external tools, documentation, consultants, and events.
• Nice-to-have: leading regulatory affairs of clinical products in a seed/series A startup.