Regulatory Specialist – AI/ML Projects
Core
Define and execute regulatory strategies for AI/ML-enabled medical devices by translating machine learning concepts into precise regulatory documentation and submissions.
Role type
Regulatory Specialist (AI/ML Medical Devices)
Builds
Regulatory documentation (DHF), FDA 510(k) and equivalent submissions, technical documentation for SaMD
Domain
Medical Technology / Artificial Intelligence / Regulatory Affairs
Deliverable
client delivery
Required skills
AI/ML design and development methodologies, SaMD requirements, software development lifecycle, ISO 13485, IEC 62304, ISO 14971, IEC 62366, MDSAP, EU MDR, FDA, Health Canada regulatory requirements, quality management systems
Preferred skills
Knowledge of clinical study requirements (IDEs, ITAs, IRB)
Technologies
None explicitly listed as tools/frameworks (via careerplan.io/jobs/D7-009-92-F64-regulatory-specialist-aiml-projects-at-clarius-mobile-health)
Responsibilities
Collaborate with ML engineers and RA team to define regulatory strategies, maintain documentation of ML algorithms and datasets, create technical documentation for model training and validation, write technical sections of FDA 510(k) submissions, manage version control and document change management
Seniority
Mid-Senior level (5+ years experience)