Lead Engineer 1 - Safety & Regulatory Engineer
Core
Ensuring safety and regulatory compliance of medical devices throughout their lifecycle, leading risk management, and coordinating technical documentation for regulatory approvals.
Role type
Lead Safety & Regulatory Engineer
Builds
Medical devices compliant with global safety and regulatory standards
Domain
Medical Device Industry / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
ISO 14971 risk management, IEC 60601-1 standards application, FDA QSR and EU MDR regulations, EMC/ESD debugging, REACH/RoHS/WEEE material compliance, technical file preparation, post-market surveillance, audit participation
Preferred skills
Master's degree in Biomedical/Electrical/Mechanical Engineering, experience with Notified Body processes
Technologies
IEC 60601 family of standards, FDA QSR, EU MDR, REACH, RoHS, WEEE
Responsibilities
Lead safety risk management activities (hazard identification, risk analysis, control verification), interpret and apply global medical device regulations to product design, coordinate Informative and formal tests with external test houses, support R&D on safety/regulatory issues, conduct post-market surveillance (complaints, incidents, field actions), participate in internal and external audits, mentor junior engineers on safety and regulatory matters
Seniority
Senior, hands-on IC with leadership responsibilities