Fresenius Medical Care
Regulatory Affairs Expert
Job Description
**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.
**Regulatory Documentation**
+ Preparation, maintenance, review, and approval of global regulatory product documentation, including Global Technical Documentation and Registration Files, ensuring strategic alignment and compliance.
+ Oversee the development, harmonization, and approval of content for Instructions for Use (IFU), Service Manuals (SM), Installation Guides (IGL), and product label...
+ 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.
**Regulatory Documentation**
+ Preparation, maintenance, review, and approval of global regulatory product documentation, including Global Technical Documentation and Registration Files, ensuring strategic alignment and compliance.
+ Oversee the development, harmonization, and approval of content for Instructions for Use (IFU), Service Manuals (SM), Installation Guides (IGL), and product label...