A leading Medical Devices company is actively recruiting for a Regulatory Affairs Expert to be based in Dubai, UAE.

Applicants must have a Valid Ministry of Health License.

Please note that you must meet all the criteria set out below for your application to be considered. Suitable candidates will be contacted within 5 working days. If you are not contacted by us within that time, please consider your application unsuccessful on this occasion.

The main responsibilities will include:

• Ensuring compliance with regulations.
• Defining and executing regulatory plans and managing timelines to achieve the stated goals.
• Reviewing new product submission and variation dossiers for submission.
• Approvals & maintenance of regulatory licenses and applications.
• Collate and distribute all technical and regulatory documentation internally and externally.
• Prepare and complete the registration process for products.
• Updated on relevant local regulations and guidelines.
• Collects relevant regulatory information.
• Analyse KPI\xe2\x80\x99s and other trends related to customer issues.
• Maintenance of assigned, authorized products through timely submission of variations, renewal applications.
• Maintain a positive relationship with internal and external regulatory contacts.
• Maintaining data in information systems or databases
• Reporting adverse event & product quality complaints as per company guidelines.

To be successful you will need to meet the following:

• Applicants must have a Valid Ministry of Health License.
• University Degree in Science. Preferably Medical/Pharmaceutical.
• 5 years regulatory affairs experience in medical and/or pharmaceutical field.
• Good knowledge of regulatory requirements, regulations & guidelines.
• Demonstrated ability to manage and build a regulatory.
• Proficient user of modern IT and office software.
• Performance-driven individual, with a strong sense of urgency, exceptional organizational credibility, and deep understanding of the business.
• Excellent written and verbal communication skills in English. Arabic is a plus.
• Applicants should be available for face-to-face interviews in the location mentioned above.

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Kinetic Business Solutions