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Regulatory Affairs Expert
7 days ago
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.**
**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.
- 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’s and other trends related to customer issues.
- 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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