Regulatory Affairs Expert
Core
Manage global regulatory product documentation, ensure compliance with medical device regulations, and lead regulatory strategies for cloud-hosted medical software.
Role type
Senior Regulatory Affairs Expert (Medical Devices)
Builds
Global regulatory product availability and compliance for medical devices and cloud-based software
Domain
Medical Devices / Health Software / Regulatory Affairs
Required skills
Global medical device regulations (MDR, FDA, NMPA), Cloud compliance frameworks, Cybersecurity, Data protection (GDPR), Quality management standards (ISO 13485, 14971, 62304, 82304-1, 81001-5-1), Technical documentation management, Regulatory strategy, Change management
Preferred skills
Experience with Notified Bodies, Software lifecycle management
Technologies
Cloud infrastructure, Medical device software platforms
Responsibilities
Manage global regulatory product documentation including technical files and registration dossiers, Ensure compliance with regulatory standards throughout product design and development, Coordinate regulatory approvals and change notifications with Notified Bodies and Authorities, Lead regulatory assessments for product and process changes including software updates and cloud-infrastructure changes, Drive regulatory strategies for cloud-hosted medical software
Seniority
Senior, hands-on IC