Regulatory Expert - Medical Devices & Drugs (Regulatory Intelligence Platform)
About CogniLens
CogniLens is a Berlin-based startup transforming how regulatory science supports the drug development lifecycle. 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
After building our MVP and preparing pilot collaborations with biotech and CRO partners, we’re now expanding our leadership team.
We’re looking for an experienced Regulatory Affairs professional to join us as an Advisor or Part-time Co-founder.
You’ll help shape how AI can bring clarity, consistency, and speed to clinical trial and regulatory design.
You might be:
• A former MDA/EMA/FDA reviewer,
• A Regulatory Affairs Head or Director in medtech, biotech, pharma, or CRO,
• Or an experienced consultant who’s seen first-hand how fragmented, manual, and unpredictable regulatory feedback can be.
We’re looking for someone who:
• Understands the end-to-end drug development and approval lifecycle,
• Can guide how AI tools align with regulatory logic and submission standards,
• Wants to shape—not just advise—how technology transforms regulatory practice.
Details
• Location: Berlin (preferred) or remote (EU/UK experience required)
• Commitment: Advisory / Part-time (a few hours per month)
• Equity: Depending on involvement (no capital required)
Art der Stelle: Vollzeit, Teilzeit
Gehalt: $43,66 - $52,58 pro Stunde
Arbeitsort: Homeoffice
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CogniLens is a Berlin-based startup transforming how regulatory science supports the drug development lifecycle. 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
After building our MVP and preparing pilot collaborations with biotech and CRO partners, we’re now expanding our leadership team.
We’re looking for an experienced Regulatory Affairs professional to join us as an Advisor or Part-time Co-founder.
You’ll help shape how AI can bring clarity, consistency, and speed to clinical trial and regulatory design.
You might be:
• A former MDA/EMA/FDA reviewer,
• A Regulatory Affairs Head or Director in medtech, biotech, pharma, or CRO,
• Or an experienced consultant who’s seen first-hand how fragmented, manual, and unpredictable regulatory feedback can be.
We’re looking for someone who:
• Understands the end-to-end drug development and approval lifecycle,
• Can guide how AI tools align with regulatory logic and submission standards,
• Wants to shape—not just advise—how technology transforms regulatory practice.
Details
• Location: Berlin (preferred) or remote (EU/UK experience required)
• Commitment: Advisory / Part-time (a few hours per month)
• Equity: Depending on involvement (no capital required)
Art der Stelle: Vollzeit, Teilzeit
Gehalt: $43,66 - $52,58 pro Stunde
Arbeitsort: Homeoffice
Apply tot his job
Apply To this Job