Principal Regulatory Affairs Specialist
Core
Drive global regulatory strategy and submissions for AI-driven medical products (SaMD, AI/ML algorithms, mobile medical apps) to achieve commercial clearance.
Role type
Principal Regulatory Affairs Specialist (SaMD/AI/ML)
Builds
Global regulatory strategies, FDA 510(k)/De Novo, EU MDR CE Marking, and digital health filings for AI/ML-enabled devices.
Domain
Medical Devices / Digital Health / AI/ML
Deliverable
production ML models
Required skills
Global regulatory strategy, SaMD/AI/ML submissions, FDA/EU Notified Body engagement, software change impact analysis, regulatory intelligence, mentorship, IEC 62304, ISO 14971, IEC 82304-1
Preferred skills
Predetermined Change Control Plans (PCCPs), clinical trial strategy
Technologies
FDA 510(k), De Novo, EU MDR, GMLP, PCCPs, IEC 62304, ISO 14971, IEC 82304-1
Responsibilities
Author and execute global regulatory strategies; develop submission strategies for AI/ML-enabled devices; lead interactive communications with regulatory agencies; maintain regulatory compliance and support Quality organization; evaluate software changes for necessary filings; track evolving digital health policies; provide guidance and training to engineering and product teams.
Seniority
Principal, hands-on IC with strategic oversight