Regulatory Lead

Opticians and eye clinics often find small spots on the back of the eye. Most of them are harmless, but a few are uveal melanoma, a cancer where early detection makes a critical difference. Today many patients are referred unnecessarily, while the patients who need care risk being found too late.

Eyedentity is changing that. Our AI software analyses fundus images and helps eye care professionals tell harmless findings from those that need further investigation. The technology is based on research from Karolinska Institutet, and published studies show that around 90% of false referrals can be avoided. Our first product is a Class IIb medical device on its way to CE marking. Next, the platform will expand to more eye diseases and new markets, starting in the EU and then the US.

We are a small team with a background in clinical research and machine learning, based at S:t Eriks Eye Hospital and backed by Norrsken and Karolinska Institutet.

The role

Regulatory is at the core of our strategy, not a support function. As Regulatory Lead you own our regulatory work and act as our Person Responsible for Regulatory Compliance (PRRC). You will set up a regulatory function that is modern, efficient and built to scale with every new disease module we add.

You will:

• Own the regulatory strategy and plan for CE marking and ongoing MDR compliance
• Drive and maintain the technical documentation and be our main contact with the Notified Body
• Make sure intended purpose, claims, labelling and IFU are consistent and well supported
• Give regulatory input on product development, risk management, clinical evaluation, cybersecurity and post market surveillance
• Run and develop our ISO 13485 quality management system
• Prepare the organisation for upcoming requirements under the EU AI Act and, over time, the FDA

Who you are

You have taken a medical device through regulatory work before and you want to do it again, this time with full ownership. You are curious about new ways of working and see AI as a tool that makes regulatory work better, not as a threat. You are honest and easy to work with, and you enjoy sharing what you know.

We think you have:

• A university degree in engineering, life sciences, medicine, pharmacy, law or a related field
• Hands-on experience with EU MDR and technical documentation within a QMS
• The qualifications to act as PRRC under MDR Article 15
• Fluent English and a Swedish work permit

It is a plus if you have:

• Experience 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 and a central role in a company where regulatory is the competitive edge
• A meaningful product with clear patient benefit
• Short decision paths and colleagues with deep clinical and ML expertise
• A clear path to grow with the company, including towards a leadership role
• Competitive salary with stock options
• Hybrid work with time in the office each week, shared lunches and a sustainable pace

Apply

Eyedentity is working with SallyQ on this recruitment. We review applications on a rolling basis, so please apply as soon as you can. Questions are welcome. Contact Sandra Bydell Sveder, Senior Recruitment Consultant at SallyQ, at sandra.sveder@sallyq.se or +46 76 319 96 88.

Before you publish, check these:

• Funding and investors: Confirm with Per that the investor wording and the "around 90%" figure are fine to use externally.
• "World's first": Per said they are first in the world. Ask whether that claim can be published.
• Reporting line: I left it out because it is still unclear whether the role reports to Per or to a CPO.
• The AI Act and FDA: I included them as future areas of responsibility. Remove them if Eyedentity would rather not mention them.