Contract: 1 year with possible extension
Location: Egypt (3 days from the local office (Cairo)- 2 from home)
Kelly FSP, on behalf of one of the top pharmaceutical clients, is looking for Regulatory Affairs Associate.
In this role, you will be drawing on relevant expertise and information from both internal and external sources, contributing towards the preparation and maintenance of regulatory information on the regulatory status of Medical Devices.
Job Responsibilities:
- From varying data sources, identify and extract required data/documents to create and maintain product records
- Coordinate, prepare, and provide regulatory documentation to support regional regulatory submission and/or other type of applications
- Provide technical review of data that will be incorporated into regulatory submissions and/or other type of applications
- Provide services to enable execution of regulatory strategies for new projects or changes to existing devices
- Maintain data integrity of product lifecycle management
- Assist other members of the RA departments with issues as they arise
- Provide valuable input for the planning and development of a centralized regulatory database system to help identify and align both local and global regulatory organization.
Qualifications
- Experience with the full cycle of medical devices registration - including submission to local authorities.
- Successful graduation in a Life Science degree or equivalent.
- Proven data administration experience.
- Strong database experience.
- Strong team player.
- Outspoken high standard of accuracy and attention to a very high level of detail.
- Strong MS Excel skills. Able to handle and manipulate large excel sheets.
- Arabic and English proficiency.
- EU MDR knowledge (nice to have).
If this role seems interesting, then don't hesitate to apply today!
