Regulatory Lead

Eyedentity AB; Stockholms kommun; On-site; SEK 900,000 - 1,300,000; Full time

Benefits offered by this job

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Job summary

Eyedentity AB, based in Stockholm, seeks a Regulatory Lead to own regulatory work end-to-end and serve as PRRC. You will drive CE marking, MDR compliance, and the transition to a new eQMS, shaping how quality and regulatory work is done as the company grows.

The role is hands-on and requires a proactive, decision-driven mindset. You will write, review and drive regulatory activities, collaborating with product and clinical teams to ensure proper labelling, risk management and post-market

Qualifications

• University degree in engineering, life sciences, medicine, pharmacy or law.
• Hands-on experience with EU MDR and technical documentation within a QMS.
• Fluent English and a Swedish work permit.

Responsibilities

• Own regulatory strategy and plan for CE marking and MDR compliance.
• Drive technical documentation and be the main contact with Notified Body.
• Lead certification of new modules as the platform grows.
• Ensure consistency of intended purpose, claims, labelling and IFU.
• Provide regulatory input on product development, risk management, clinical evaluation, cybersecurity and post-market surveillance.
• Run and develop ISO 13485 QMS.
• Prepare for EU AI Act and groundwork for FDA submission.

Skills

Regulatory strategy

MDR compliance

Quality systems

Education

University degree in engineering, life sciences, medicine, pharmacy or law

Job description

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

Eyedentity is changing that. Our AI software analyzes fundus images and helps eye care professionals separate harmless findings from those that need a closer look. The technology is built on research from Karolinska Institutet, and published studies show that around 90% of false referrals can be avoided.

Our first product, a Class IIb medical device, is on its way to CE marking, and we expect to submit our application this autumn. That is only the beginning. The platform will grow to cover four to five eye diseases, with the next product planned for approval in 2027. All of them will go through CE marking and, from 2027, we start preparing for the FDA.

The Role

Regulatory is at the core of our strategy, not a support function. As our first Regulatory Lead you own our regulatory work end to end and act as our Person Responsible for Regulatory Compliance (PRRC). Right now the role is very hands‑on: you write, review and drive the work yourself. We are also replacing our eQMS and building some of our own tools, so you will have a real say in how quality and regulatory work is done here. As the company grows, so will your responsibilities, at a pace that matches your experience.

Responsibility

• Own the regulatory strategy and plan for CE marking and ongoing MDR compliance.
• Drive the technical documentation and be our main contact with the Notified Body
• Lead the certification of new disease modules as the platform grows
• 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 us for the EU AI Act and lay the groundwork for the FDA application

Your Profile

You have taken a medical device through regulatory work before, and now you want to do it with full ownership. You know the regulations well and enjoy turning complex requirements into clear actions. You are curious, quick to learn and see AI as a tool that makes regulatory work better. You are comfortable speaking up, setting priorities and making decisions when not everything is known. You are honest, unpretentious and happy to share what you know.

Qualifications / Requirements for position

• 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
• Fluent English and a Swedish work permit

It is a plus if you have:

• Experience with both QA and RA
• The qualifications to act as PRRC under MDR Article 15. Not there yet? If you are the right person, we can bring in PRRC support for a period while you grow into it
• Experience with SaMD, AI or ML products
• Taken a Class IIa or IIb device through Notified Body review
• Experience with FDA submissions, such as 510(k) or De Novo
• Working knowledge of ISO 14971, IEC 62304 and IEC 62366
• Startup experience and Swedish

Life in a startup

We are a small but growing team based at S:t Eriks Eye Hospital, with backgrounds in clinical research and machine learning, and backed by Norrsken and Karolinska Institutet. A new CTO and a sales lead are joining around the new year, and more roles are on the way. Every person who joins us builds a function that did not exist before. The pace is high, everyone takes responsibility, and we solve problems as they come up.

We do not always have the answers in-house, but together we have a broad network and we are not afraid to test new ways of doing things. If you like the idea of figuring it out, asking around and trying again, you will feel at home here. We also believe in a sustainable pace, shared lunches and going home at a reasonable hour. As one of our early key hires, you will also be offered stock options and become a part owner of what we build.

Location

• 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.