Associate Regulatory Specialist
Core
Maintain CE Technical Files and registrations for international regulatory agencies while ensuring compliance with ISO, CE, FDA, and other international/local regulations for medical devices.
Role type
Associate Regulatory Specialist (Medical Devices)
Builds
Regulatory submissions and technical documentation for spinal and orthopedic devices
Domain
Medical Devices / Orthopedics / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
regulatory compliance knowledge, documentation assembly, literature search, labeling review, clinical report review, multi-tasking, detail orientation
Preferred skills
experience in regulated industry (medical devices), understanding of spinal and orthopedic surgical techniques and devices
Technologies
ISO, CE, FDA regulations, regulatory submission systems
Responsibilities
Obtain documentation from Product Development and Quality Assurance to maintain CE Technical Files; Assemble documentation for regulatory submissions; Review technical documents and labeling for compliance; Perform literature searches to support submissions; Monitor agency laws and regulations to ensure company compliance
Seniority
Entry-level to Mid-level, individual contributor