Kinetic has partnered with a leading Medical Device company who are hiring a Regulatory Affairs & Quality Assurance Specialist to be based in Saudi Arabia.
Please note that due to Saudization, only Saudi Nationals can be considered for this role.
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:
- Ensure regulatory affairs and quality assurance processes and procedures are in place in the assigned region and compliant with local authorities.
- Monitor, review, analyse, and translate all regulatory requirements of the Medicines Regulatory Authority
- Define and execute strategies for regulatory approvals to support business plans.
- Liaise closely with Health Authorities, assigned distributors, and agents ensuring the optimum relationship between the regulatory authorities, distributors, and company.
- Responsible for approvals & maintenance of regulatory licenses.
- Coordinate GMP and GDP inspection in the company activities.
- Support the implementation and continuous improvement of the Quality System.
- Ensuring that all SOPs are in place, updated & training has been conducted across the business.
- Coordinate and facilitate quality risk management.
- Managing the audits and inspections preparation & execution.
- Ensuring temperature conditions are controlled and monitored during storage and distribution of products that are temperature sensitive.
To be successful you will need to meet the following:
- Please note that due to Saudization, only Saudi Nationals can be considered for this role.
- Degree in Pharmacy.
- Minimum 2-4 years of experience in Regulatory Affairs & Quality Assurance.
- Minimum 2-4 years of experience as a Pharmacist.
- Good Knowledge of QA and RA requirements, local compliance regulations, and industry practices.
- Good Scientific knowledge & Project management skills.
- Applicants should be available for face-to-face interviews in the location mentioned above.
Must Read: How to Create an ATS-Friendly CV That Will Accelerate Your Career.
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