Regulatory Affairs Expert
Core
Manage global regulatory product documentation, ensure compliance with standards, and coordinate approvals for medical devices.
Role type
Regulatory Affairs Expert (Medical Devices)
Builds
Medical device registrations and compliance dossiers
Domain
Medical Devices / Regulatory Affairs
Deliverable
client delivery
Required skills
Global regulatory documentation management, FDA CFR/NMPA/MDR 2017/745 knowledge, ISO 13485/14971/IEC 60601 familiarity, product design compliance coordination, Notified Body communication, registration and renewal management
Preferred skills
Quality management and risk management standards knowledge, development and manufacturing process understanding
Technologies
None stated
Responsibilities
Manage global regulatory product documentation, Ensure compliance with regulatory standards and testing requirements, Coordinate regulatory approvals and change notifications, Ensure global regulatory product availability, Coordinate regulatory product strategies, Lead regulatory aspects of product and process changes
Seniority
Senior, 8-10 years experience