Regulatory Scientist (QARA)
- Where: UK
- Closing Date Open
- How to apply Applications in writing together with full CV to Lyn Stoddern: [email protected]
We are looking to recruit a new Quality and Regulatory Scientist to join our existing Quality and Regulatory Team. Working closely with the QARA and QA Managers, you will assist in maintaining compliance with all applicable standards and statutory requirements necessary to the continued business activities of the Mast Group Limited.
Mast is a market leading manufacturer and supplier of IVD solutions for clinical, industrial and veterinary markets. We are ISO 9001 and ISO 13485 certified.
The Quality and Regulatory Scientist role will ensure that all required aspects of Mast’s Quality Management Systems are implemented, controlled and managed in accordance with applicable international Quality Management standards.
The Quality and Regulatory Scientist will work closely with both Research and Development and Quality Control personnel in the compilation, storage and accessibility of product technical documentation in accordance with applicable regulatory requirements.
In addition the Quality and Regulatory Scientist will provide support and advice to Company departments in regulatory and quality assurance matters, and this will include equipment calibration and monitoring: process verification and validation; measuring and monitoring of processes; document and procedure training process, as well as investigation and rapid resolution of complaints, recall and vigilance reporting, and liaison, as required, with National Competent Authorities, ensuring that necessary improvements and corrective and preventative (CAPA) measures are identified and implemented.
Working in conjunction with QA/QARA management team the Quality and Regulatory Scientist will be involved in the scheduled of internal audits and assist with all aspects of global regulatory enquiries and issues.
We are looking for someone with a formal qualification in life science, such as microbiology or biomedical science, together with qualifications and working experience within the QMS environment.