Description
Position Summary:The Regulatory Affairs representative will be involved with EU regulatory activities within CDD Fremont, particularly in regards to Technical File creation and updates.
Key Responsibilities:
- Prepares documents necessary for new and continuous product market access in the EU, including technical file creation and updates for CE marking.
- Supports registration of products in the EU.
- Interacts with R&D and other cross functional departments to obtain documents needed for preparation of regulatory files.
- Helps with the design and implementation of a new template for technical file creation.
- Helps train and coordinate CE mark activities of more junior regulatory staff.
- Provides input for regulatory requirements pertaining to the IVDD and current EU regulations and publications.
Minimum Requirements/Qualifications:
- Bachelor's Degree in a scientific discipline
- Minimum 5-8 years direct experience in regulatory affairs with extensive experience with technical files and CE marking.
- Experience in making regulatory assessments with strong knowledge and understanding of in vitro diagnostics regulations, particularly the IVDD and international standards.
- Must be able to write clear, understandable technical documents, i.e. regulatory documentation or scientific presentations.
- Excellent verbal communication skills.
Non-Negotiable Hiring Criteria:
- Experience in the preparation of EU technical files.
- Strong knowledge of the IVDD.
To find out more about Real please visit www.realstaffing.com