Regulatory Affairs and Quality Assurance Specialist

2 weeks ago


مصر, Egypt Kinetic Full time

A leading **Medical Device** company is actively recruiting a **Regulatory Affairs and Quality Assurance Specialist for** their **Egypt** office.

**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.

**To be successful you will need to meet the following**:

- **Bachelor’s degree.** Preferably in a scientific discipline such as Science, Engineering, or similar. Regulatory Affairs Certification (RAC) is a plus.
- **Minimum 3 - 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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