Regulatory Affairs Specialist
Al Mazroui Medical & Chemical Supplies
مجموع سنوات الخبرة :9 years, 6 أشهر
- Fully responsible for the registration of medical equipment/supplies in UAE Ministry of Health.
- Preparation, review and submission of documents for new medical device and drug registrations, product license renewals, site registrations, variations and marketing authorization holder registration.
- Responsible for presentation of registration documents to the local authorities.
- Act as a link between the organization and the regulatory authorities ensuring that consumer products are in compliance with appropriate local legislation. Establish contacts with local authorities and act as a main contact for regulatory issues.
- Establish and maintain good relationships with Ministries of Health, regulatory authorities and medical device associations, ensuring optimum visibility and priority to product registrations.
- Close up follow up with health authorities on submitted material and new regulations to update
stakeholders and be able to create feasible strategy.
- Provide all regulatory documentation needed to support tenders.
- Review and amend label safety updated according to current registered information to comply with COO approval and local labeling requirements.
- Review contracts/agreement and provide recommendations as well as negotiated terms and conditions.
- Maintain and handles company sensitive information with discretion to ensure confidentiality both soft and hard copies kept in file.
- Directly in contact with the suppliers to collate the necessary information, segregating documents and
responding to all requests.
- Directly reporting to the Board of Directors
- Devising and maintaining office systems including data management and filing.
- Organizing, preparing agendas for and taking minutes of Board meetings and annual general meetings.
- Dealing with correspondence, collating information and writing reports, ensuring decisions made are communicated. Contributing to meeting discussions as and when required.
- Establish general filing system for safekeeping of corporate records, contracts, personnel documents with confidentiality.
- Manage day-to-day activities and ensure timely completion of events on specified time.
- Screening phone calls, inquiries and request and handling them with appropriate.
- Dealing with incoming email, social post, often corresponding on behalf of the manager.
- Ensure that invoices from Suppliers and Subcontractors reconciled with Purchase Order.
- Compile and maintain records of business transactions and office activities of establishment, performing variety of following or similar clerical duties and utilizing knowledge of systems or procedures.
- Check, sort and dispatch invoices to site for confirmation, to Accounts Payable Division for final settlement.
- Checking the accuracy and completeness of invoices before receiving and recording into the system.
- Full responsible for archiving of documents for easy retrieval. Keeps record of documents filed.
- Provides accurate information to ensure the efficiency and effective execution of transactions and payments for the benefit of the company and also the suppliers and subcontractors.
- Formulates excel formulas/data linking to improve processing and generation of reports.
- Contribute on procedure enhancement of existing work that can provide an improve procedure for an effective and efficient work.
- Can communicate well both internal and external customers.
- Screen incoming calls and correspondence and responds independently.