Our Team

About CogniLens

CogniLens is a Berlin-based startup transforming how regulatory science supports drug and medical device development.

Sponsors lose millions and critical time due to avoidable protocol amendments, design gaps, and regulatory objections. We’re building a regulatory intelligence platform that anticipates what regulators will flag — before they do.

Our AI analyzes clinical protocols, technical documentation, and development strategies to identify likely regulatory risks — enabling smarter design and faster submissions.

The Opportunity

We’re seeking an experienced Regulatory Affairs Expert (Drugs and/or Medical Devices) to help shape how AI aligns with real regulatory logic, reviewer behavior, and submission standards. This role may be structured as advisory or part-time with potential for deeper involvement.

You Bring

• Strong understanding of the end-to-end drug and/or medical device development lifecycle
• Experience with major regulatory frameworks (FDA, EMA, MDR/IVDR, 510(k), PMA, IND/NDA, etc.)
• Background as a former regulator, Regulatory Affairs Head/Director, or senior consultant
• Interest in shaping technology that transforms regulatory practice

Details

Location: Berlin (preferred) or remote (EU/UK/US regulatory experience required)

Commitment: Part-time

About CogniLens

CogniLens is a Berlin-based startup transforming how regulatory science supports drugs and medical devices. Every year, clinical trial sponsors lose millions of dollars and months of progress due to protocol amendments that could have been predicted — if regulatory reasoning were more transparent.

We’re building a regulatory intelligence platform that sees what regulators will flag — before they do.

Our platform analyzes study protocols and identifies design elements likely to trigger regulatory feedback or delays, giving teams earlier insight and faster submissions.

The Opportunity

We’re looking for a Head of AI (Full-Stack) to own and shape the technical and AI foundation of CogniLens.

In this role, you’ll define how modern AI — including LLMs, reasoning systems, and structured regulatory knowledge — can bring clarity, consistency, and speed to regulatory decision-making in life sciences.

What You’ll Do

• Own the end-to-end AI and platform architecture, from regulatory knowledge modeling to production-ready systems
• Translate regulatory guidelines, precedents, and feedback into a structured knowledge layer / knowledge graph
• Design, prototype, and iterate on ML and LLM-based models for regulatory risk detection and reasoning
• Build and maintain end-to-end AI systems including data pipelines, model training, and APIs
• Set up robust evaluation loops (metrics, error analysis, human-in-the-loop)
• Collaborate closely with regulatory domain experts to encode real-world reasoning
• Own the technical roadmap and make architecture decisions appropriate for an early-stage product

We’re Looking for Someone Who

• Has hands-on experience with LLMs and reasoning-based or knowledge-graph-driven architectures
• Is comfortable building full-stack AI systems (backend, data pipelines, model serving)
• Has strong proficiency in Python and modern ML tooling (LangChain, vector databases, MCP, etc.)
• Can own technical decisions while collaborating with non-technical domain experts
• Thrives in an early-stage environment where autonomy and pragmatic decision-making matter
• Is excited to build a category-defining product at the intersection of AI and regulatory science

Details

Location: Berlin (preferred) or remote