Head of Legal

1 dag sedan

Stockholms kommun, Stockholms län, Sverige Dentail AI Heltid 655 236 kr - 982 854 kr Kontrakt

Lead the legal and regulatory strategy that allows Dentail to operate as a certified medical device across multiple jurisdictions. You will own both the day‑to‑day legal function of the company and the long‑term pathway to a leading certification portfolio — reporting directly to the CEO.

What you’ll do

  • Own and continuously improve our EU MDR and FDA compliance programme, working alongside management and external notified bodies.
  • Lead commercial legal matters: SaaS and data processing agreements with clinic groups, partner integration contracts, and clinical research collaboration agreements.
  • Build and maintain the company's GDPR and data governance framework in close coordination with engineering and the CMO.
  • Advise the executive team on regulatory risk as we expand into new geographies.

What we’re looking for

  • Qualified lawyer (EU or UK jurisdiction) with 7+ years of post‑qualification experience. A significant portion of which in medical device or digital health regulation is a clear advantage.
  • Hands‑on experience with EU MDR — you have navigated a Class IIa or Class IIb device through the conformity assessment process.
  • Working knowledge of the FDA medical device regulatory framework; direct submission experience is a strong plus.
  • Pragmatic legal judgment: you understand that a 20‑page contract is not always better than a 4‑page one, and you know when to take risk and when to hold firm.
  • Fluency in English required; Swedish is an advantage.