MDR Compliance Associate
Core
Maintain and organize technical documentation for AI-powered software as a medical device (SaMD) to ensure compliance with EU MDR regulations.
Role type
MDR Compliance Associate (Regulatory Affairs)
Builds
Audit-ready technical files and clinical evaluation documentation for SaMD products
Domain
Healthcare / Medical Device Regulation (EU MDR)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
EU MDR technical documentation (Annex II/III), change management for software, clinical evaluation processes, traceability management, eQMS usage, regulatory impact assessment
Preferred skills
Data analysis, research methodology, LLM-based tools, project management, scripting
Technologies
Ketryx, eQMS, Notion, Linear
Responsibilities
Maintain MDR technical documentation files (Annex II/III), update technical files during software changes, maintain clinical evaluation documentation, work within traceability tools, coordinate documentation updates, support internal audits
Seniority
Junior to Mid-level, hands-on IC