Regulatory Affairs And Quality Assurance Specialist
2 months ago
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. To be successful you will need to meet the following:
- Bachelor\xe2\x80\x99s degree. Preferably in a scientific discipline such as Science, Engineering, or similar. Regulatory Affairs Certification (RAC) is a plus.
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Kinetic Business Solutions
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