- Ensuring imported products claims are complied with EDA regulations and legal requirements.
- Preparing and uploading all the documents required by EDA for the importation requests or products registration or variation.
- Liaising and negotiating with regulatory authorities.
- Maintain regulatory submissions documentation and track status.
- Keep up-to-date with changes in regulatory guidelines.
- Manage product registration activities for new and existing products.
- Arranging and finishing governmental regulatory inspections and audits.
- Following up on daily basis with EDA all company submissions.
- Representing new product registration files for our suppliers.
- Dealing and finishing all NTRA approvals.
- Arranging and dealing with the supplier regarding all new and updated certificates.
- Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labelling changes.
- Identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance.
- Participate in internal or external audits.
- Prepare or direct the preparation of additional information or responses as requested by regulatory manager.
Bachelor's degree in a relevant field such as Pharmacy & biomedical engineering .Proficiency in English & Arabic spoken & written.Years of experience from 2 to 5.Experience in Medical Devices is preferable.Proficiency in MS Office: Word, Excel, PowerPoint.Excellent communication and negotiation skills.Problem solving and time management skills.