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 & Software)
Builds
Global regulatory product availability and compliance for medical devices and cloud-based software
Domain
Medical Devices / Health Software / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | client delivery | infrastructure
Required skills
Global medical device regulations (MDR, FDA, NMPA), Cloud-based software compliance, Regulatory documentation management, Change management, Notified Body coordination, Risk management standards (ISO 14971, IEC 62304)
Preferred skills
Cybersecurity frameworks, Data protection (GDPR), Cross-border data transfer requirements
Technologies
MDR 2017/745, FDA SaMD Guidance, IMDRF SaMD Principles, NMPA, ISO 13485, ISO 14971, IEC 62304, IEC 82304-1, IEC 81001-5-1
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, Ensure global regulatory product availability aligned with commercial strategy, Drive regulatory assessments for product and process changes including software updates, Lead regulatory aspects of product and process changes including regulatory documentation
Seniority
Senior, hands-on IC
