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Randox is currently recruiting for a Registration and Quality Officer to be based in South Korea. The successful applicant will be responsible for the preparation, submission and maintenance of product registrations for our array of medical diagnostics products and devises in South Korea in conjunction with our product registration team at our Headquarters in Northern Ireland. This role will also involve liaising with the Ministry of Food & Drug Safety (MFDS) Regulatory Authority. The Registration and Quality Officer will also carry out duties required of the Quality representative on the Randox Korea Office.
The Job Assist Quality Assurance at Randox Headquarters with all requirements of registering the Randox product line in South Korea Prepare regulatory documentation, review and interpret previous regulatory documents, technical information and performance data to ensure compliance with national regulations and standards Compile, submit and follow up on registration files to obtain and maintain marketing authorisations for IVD Medical Devices Assist with any current registration processes with MFDS for all Randox products in a highly efficient manner Provide regulatory support when required and ensure that the company¡¯s customers are serviced at the highest level of satisfaction through quality service and quick responses Follow company procedure and keep top agreed project timelines Attend training activities and trade shows on behalf of the company
The Candidate: - A bachelor degree or equivalent in Pharmacy, Chemistry, Biochemistry or a related Scientific discipline.
- Previous experience in a similar office environment
- Excellent verbal and written communication skills.
- Excellent organisational skills with an eye for detail and the ability to prioritise.
- Ability to act on your own initiative as well as part of a team.
- Fully computer literate (MS Office Packages)
- Fluent in English (essential).
- Previous experience in Regulatory Affairs (desirable)
- Knowledge and experience of Quality Systems (desirable)
This is an excellent opportunity to join an innovative international company in a growing industry, which can provide career security and genuine advancement opportunities for those who show potential.
About Randox Randox Laboratories are passionate about improving global health and saving lives through the development of innovative and pioneering products. Through our commitment and the skill of our people we have grown to be a world leader in diagnostics for clinical healthcare, toxicology, food security and providing quality solutions to over 145 countries. In order to serve our growing international markets we require high calibre applicants with scientific, engineering, software and broader business skills – including sales, marketing, logistics, finance and many more.
Central to the Randox ethos is our drive to improve healthcare worldwide and every one of our staff plays a vital role in this aim. To apply To apply for this position, please submit your CV and cover letter in English to globalrecruitment@randox.com. Please quote the appropriate job reference 19I/PRQO in all communication. |