Safety & Regulatory Engineer
Core
Plan, schedule, and manage safety and regulatory tasks for medical devices, including type testing, submission documents, and obtaining certifications from agencies like NMPA, CE, and FDA.
Role type
Senior Safety & Regulatory Engineer (Medical Devices)
Builds
Medical device product certifications and regulatory clearances
Domain
Medical Devices / Healthcare Technology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Medical device safety and compliance, Design for safety, Design for EMC, Product type testing, Regulatory submission documentation, Audit support, Project and process management
Preferred skills
Requirements Management, Systems Engineering, Requirements Analysis, Hardware Engineering, Software Design, Product Testing & Validation, Software Testing & Validation
Technologies
NMPA, CE, FDA, IEC 60601 series, ISO 14971, RoHS, WEEE
Responsibilities
Decompose system-level safety and regulatory requirements to element level, Design for safety and compliance to meet standards, Conduct product reviews and inspections, Prepare formal product type testing reports for third-party agencies, Work with agencies to obtain product certifications, Lead marketing clearance and product registrations activities internally, Support audits conducted by various international agencies
Seniority
Senior, hands-on IC