Regulatory Affairs Specialist

Sigma for Imp & Exp & Op... -
Heliopolis, Cairo

Sigma for Imp & Exp & Opera hearing Solutions -
Heliopolis, CairoPosted 1 month ago

64Applicants for1 open position

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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.