Regulatory Lead, AI Medical Device Software
Own the regulatory journey for AI that detects eye disease. Lead CE marking, MDR compliance and scalable quality systems in a hands-on role with real patient impact.
Eyedentity builds AI software that detects eye disease from fundus images. We start with uveal melanoma, a rare but often deadly eye cancer, and are building a platform that will cover a broad range of eye diseases. Our first product is a Class IIb device and we are on track for CE marking. Now we are hiring our first in-house regulatory lead.
You will own our regulatory work end to end: the plan to CE marking, the technical documentation and the day-to-day dialogue with Scarlet. It is a hands-on role. You write and review documents yourself, work directly with our engineering, ML and clinical team, and report to our CPO. You will also be our PRRC.
You will
Own the regulatory plan for CE marking and ongoing MDR compliance
Compile and maintain the technical documentation and drive the submission
Be our main contact with the Notified Body
Make sure intended purpose, claims, labelling and IFU are consistent and supported
Give regulatory input to product development, risk management, clinical evaluation, cybersecurity and post-market surveillance
Run and improve our ISO 13485 QMS
Gradually bring work we buy from consultants in house
Build a regulatory structure that scales as we add new disease modules to the platform
How you work
You are driven, structured and comfortable taking ownership. You enjoy turning complex requirements into clear actions and do not wait for someone else to create momentum. You are equally comfortable discussing priorities with management and working directly in regulatory documents.
You are pragmatic without compromising patient safety or compliance. You communicate clearly, collaborate well with different disciplines and know when to make progress independently and when to escalate a decision.
You have
A university degree in engineering, life sciences, medicine, pharmacy, law or similar
Hands-on experience of EU MDR and technical documentation for medical devices, working within a QMS
The qualifications to act as PRRC under MDR Article 15
Fluent English
Work permit for Sweden
It helps if you have
Worked with SaMD, AI or ML products
Taken a Class IIa or IIb device through Notified Body review
Working knowledge of ISO 14971, IEC 62304 and IEC 62366
Startup experience, and Swedish
What we offer
Real ownership from day one, short decision paths, and colleagues with deep clinical and ML expertise. Hybrid work allowed. Wellness allowance.
Apply
Apply with your CV and a few lines about a regulatory deliverable you owned yourself. We review applications continuously.
Please note that this is a role where you are expected to be in the Stockholm office every week, i.e. Swedish residency and working permit is a must have.
- Locations
- Stockholm office
- Remote status
- Hybrid
About Eyedentity
Eyedentity is a Swedish medtech company building AI-driven diagnostics that catch disease earlier, starting with uveal melanoma, a rare but often deadly eye cancer. Our technology analyzes fundus images taken during routine visits to the optician, flagging warning signs long before they'd otherwise be caught.
Eyedentity is built on research from Karolinska Institutet and grounded in real clinical expertise. We're backed by leading investors, including Norrsken Launcher and Karolinska Institutet Holding, and are on track for CE approval, with commercial partnerships already in place across the optician industry.
We're a small, fast-moving team where deep clinical and technical expertise meet genuine ambition: to make early, life-saving detection a normal part of an everyday eye exam. As we grow, we're looking for people who want to build something that matters, and see the impact of their work show up in patients' lives.