Senior Regulatory Affairs Specialist
Remote in CanadaRemoteFull Time
Function Health
5+ YOECandidates need 5+ years of regulatory affairs experience with medical devices, SaMD or diagnostics, and a bachelor's degree in engineering, life sciences or a related field. Hands-on 510(k), De Novo or Pre-Submission experience and working knowledge of FDA, ISO 13485, ISO 14971 and IEC 62304 are required.
AI tools
Member of Technical Staff
Remote in CanadaRemoteFull Time
Function Health
6+ YOECandidates need at least 1 year building agentic AI systems and 6 years as a full-stack or ML engineer, with production Python or Go experience. Strong skills in LLM tooling, retrieval, PostgreSQL, observability, and cloud deployment are expected.
LangGraph, PydanticAI, DSPy, LlamaIndex, FastAPI, Flask