Senior Regulatory Affairs Specialist
Core
Guide product, quality, and clinical plans through regulatory pathways for an FDA-cleared, EEG-based brain state monitoring platform (wearable sensor + Android app) to ensure safe, effective, and compliant medical device development.
Role type
Senior Regulatory Affairs Specialist (Medical Devices/Digital Health)
Builds
FDA 510(k) submissions, CE Mark documentation, and regulatory strategies for new features and platform expansion.
Domain
Medical Devices / Digital Health / Neuroscience Monitoring
Required skills
FDA submission preparation (510(k)), regulatory strategy execution, design control management, risk management (ISO 14971), change impact assessment, regulatory compliance monitoring, technical writing for audit-ready documentation, stakeholder collaboration across product/clinical/quality teams.
Preferred skills
CE Mark/EU MDR experience, software as a medical device (SaMD) expertise, EEG/neuromonitoring domain knowledge, AI/ML-enabled device development experience, cybersecurity/regulatory review, RAC certification.
Technologies
Android, EEG sensors, FDA QSR / 21 CFR Part 820, ISO 13485, ISO 14971, IEC 62304
Responsibilities
Define and execute regulatory strategies with the CEO for new features and product changes; prepare and maintain FDA 510(k) and CE Mark submissions; ensure alignment with FDA requirements and international standards (IEC 62304, ISO 14971, ISO 13485); partner with software, hardware, and clinical teams on requirements and risk analyses; evaluate product changes for regulatory impact; provide regulatory input for clinical evaluations and customer deployments; build scalable regulatory processes; monitor FDA guidance and industry practices for SaMD and AI devices.
Seniority
Senior, hands-on IC with strategic input