Regulatory Affairs Expert
Dubai, United Arab Emirates
Job Description
A leading Medical Device company is actively recruiting a Regulatory Affairs Expert for their Dubai office. 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 but not limited to:
- 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.
- 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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Job Detail
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Job IdJD1505427
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IndustryNot mentioned
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Total Positions1
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Job Type:Full Time
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Salary:Not mentioned
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Employment StatusPermanent
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Job LocationDubai, United Arab Emirates
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EducationNot mentioned