Head of Legal
1 dag sedan
Stockholms kommun, Stockholms län, Sverige
Dentail AI
Heltid
655 236 kr - 982 854 kr Kontrakt
Gratis med e-post eller Google
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Gratis med e-post eller Google
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.