About Mentis Care
Mentis Care is building AI-powered neuro-monitoring technology to transform epilepsy care. We combine wearable EEG, advanced AI models and a cloud-based clinical platform to give patients and clinicians a continuous, real-world view of neurological health. We are backed by global pharmaceutical partners.
The role
You’ll own the clinical evidence strategy and study execution for our products: what studies we run, what they must prove, and how the results support FDA submissions. You’ll work closely with the regulatory and AI teams and our study sites. This role has a target start of Q2 2027.
What you’ll do
- Design clinical studies with the regulatory team, including endpoints, sample size, reference standard and statistical approach, with support from a statistician.
- Write and maintain protocols, the clinical sections of FDA submissions, and clinical study reports.
- Plan studies for new features with the AI team, from early feasibility to pivotal.
- Bring payer evidence needs into study design, working with market access.
- Select and oversee contract research organizations (CROs) and other study vendors, managing scope, budget, timelines, monitoring and deliverables with the Clinical Trial Manager.
- Build relationships with epileptologists, EEG experts and study sites, and build an advisory network of key opinion leaders (KOLs).
What you bring
- 8+ years in clinical affairs or clinical development for medical devices, ideally diagnostics or software as a medical device (SaMD).
- At least one study that supported an FDA submission.
- Hands-on protocol writing and study design for FDA submissions.
- Knowledge of Good Clinical Practice (GCP) and ISO 14155.
Nice to have
- A background in neurology or epilepsy.
- An advanced degree in life sciences or clinical research.
Why join us
- Shape the clinical evidence behind a neurological technology platform at a pivotal stage of growth.
- Work with leading epileptologists, EEG experts and our AI team.
- Join a mission-driven company backed by global pharmaceutical partners.