Regulatory Affairs And Quality Assurance Specialist
Dubai, United Arab Emirates
Job Description
A leading Medical Device company is actively recruiting a Regulatory Affairs and Quality Assurance Specialist for their Dubai office.
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:
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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:
- Enhance and develop regulatory compliance of management system.
- Define and execute regulatory plans and manage timelines to achieve the stated goals.
- Responsible for regulatory reports, routine reports, permits, approvals, and maintenance of regulatory licenses.
- Responsible for the preparation of regulatory submissions and applicable documentation.
- Coordinate and facilitate quality risk management and product development.
- Ensure marketing materials and product information are according to regulations and policies.
- Coordinate with suppliers to resolve quality and compliance issues.
- Performs investigation of quality complaints, accidents, and incidents to determine causes and preventive measures.
- Facilitate design and process validations, release testing, and sterilization inspection activities.
- Updated on relevant regulations, guidelines, and standards.
- Bachelor\xe2\x80\x99s degree. Preferably in a scientific discipline such as Science, Engineering, or similar. Regulatory Affairs Certification (RAC) is a plus.
- Minimum 3 \xe2\x80\x93 5 years relevant experience within the Medical Devices Industry.
- Good Knowledge of QA and RA requirements, compliance regulations, and industry practices.
- Excellent verbal and written English. Arabic is an advantage.
- Motivated, proactive, dynamic, methodical, organised, and decisive.
- 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 IdJD1542609
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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