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Quality Assurance Regulatory Aff...

Kinetic Business Solutio...
Riyadh, Saudi Arabia
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Quality Assurance Regulatory Affairs Manager

Riyadh, Saudi ArabiaPosted 16 days ago
35People have clicked1 open position

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Job Description

Kinetic has partnered with a leading Medical Device company who are hiring a Regulatory Affairs & Quality Assurance Specialist to be based in Saudi Arabia.Saudi Nationals are encouraged to apply for this position.***Please take the time to read the job description, you must meet all the criteria set out below for your application to be considered. We do check all applications and 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.***Key aspects of the role include: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 AuthorityDefine 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:Saudi Nationals are encouraged to apply for this position.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.***We check all applications and 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.***

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