Kinetic has partnered with a leading Medical Device company who are hiring a Regulatory Affairs & Quality Assurance Specialist to be based in Saudi Arabia.
Candidate must have SFDA Experience.
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:
- Facilitates all related technical information and applicable documentation for licensing of products.
- Collaborate with cross-functional teams to address regulatory issues and ensure compliance with regulatory standards, regulations, and guidelines.
- Coordinate internal quality audits.
- Assist in developing a plan and implementation of a Quality Management System.
- Work closely with the Quality Management team for all Quality-related matters including complaints procedures.
- Provide support to the sales team and supply chain management for tenders and customer requests.
- Lead or support RAQA projects and assignments as required.
To be successful you will need to meet the following:
- Bachelor’s degree, preferably Pharmacy or Pharmaceutical Sciences.
- Minimum 3 – 4 years’ experience in Regulatory Affairs and Quality Assurance within the Medical Devices in the Middle East Region.
- Must have SFDA Experience.
- Experience with International Quality and Regulatory Standards (e.g., ISO 9001, ISO 13485, Medical Device Regulations).
- Excellent verbal and written English.
- Willingness to travel as required.
- Applicants should be available for face-to-face interviews in the location mentioned above.
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