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 lead the FDA submissions that bring our wearable EEG device and AI seizure detection software to market. You’ll also plan how we register them in other markets, starting with Brazil. You’ll work closely with R&D, the AI team, Quality and Clinical Affairs. The role will have a target start date of Q2 2027
What you’ll do
- Prepare and manage FDA submissions: Pre-Submissions, 510(k)s for the wearable device and the AI software (including a predetermined change control plan, or PCCP), and De Novo requests for new features.
- Write regulatory strategy documents, predicate comparisons and substantial equivalence arguments.
- Coordinate submission inputs from R&D, AI, Quality and Clinical, including software documentation (IEC 62304), cybersecurity, human factors and labeling.
- Lead FDA interactions, including meetings and responses to Additional Information requests.
- Plan and prepare registrations outside the US: first Brazil (ANVISA, with a local partner), then Europe (EU MDR) and Health Canada.
- Review product claims, labeling and marketing materials for regulatory consistency.
- Track FDA guidance and policy on AI-enabled devices.
What you bring
- 8+ years in medical device regulatory affairs, including 3+ years in a lead role.
- At least one 510(k) or De Novo led from start to clearance.
- Working knowledge of software and AI device requirements, including software as a medical device (SaMD), PCCPs and cybersecurity.
- Excellent technical writing in English.
Nice to have
- Experience with neurology or EEG devices.
- Regulatory Affairs Certification (RAC).
- Experience with ANVISA, EU MDR or Health Canada submissions.
Why join us
- Lead the regulatory path for a neurological technology platform at a pivotal stage of growth.
- Work across wearable EEG, AI software and international markets.
- Join a mission-driven company backed by global pharmaceutical partners.