Regulatory Affairs Expert

**General:**

+ Works independently on tasks and projects within the scope of Product Regulatory Affairs, ensuring compliance with applicable regulations and standards.
+ Establishes and manages priorities effectively to meet deadlines and align with business and regulatory requirements.
+ Exercises sound judgment makes informed decisions within their area of responsibility and assumes accountability for outcomes.
+ Provides technical guidance and support to Junior Regulatory Affairs Experts, fostering their development and ensuring high-quality deliverables.

**Your responsibilities:**

+ Manage global regulatory product documentation, including technical files, registration dossiers, IFUs, and labeling
+ Strong knowledge of global medical device regulations, including **MDR 2017/745** , **FDA SaMD Guidance** , **IMDRF SaMD Principles** , **NMPA** , and requirements for cloud‑based medical software.
+ Ensure compliance with regulatory standar...