Regulatory Affairs Specialist

Sigma for Imp & Exp & Op...

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.