Quality Assurance and Regulatory Affairs (QARA) Specialist

at  Mast Group Limited

Mast Group Ltd. are a world class manufacturer and supplier of diagnostic products for clinical, industrial and veterinary testing. As an independent company, since 1959, our commitment to maintaining integrity and customer satisfaction, combined with innovation in in-vitro diagnostics, has resulted in improved clinical decisions and pathways.
We are looking to recruit a highly skilled and conscientious Quality Assurance and Regulatory Affairs Specialist to join the team based in Bootle with a requirement to travel to Bootle and Deeside/Daresbury locations as required. The job holder will be an integral part of the team, ensuring development, evaluation and registration of products for diagnostic microbiology in line with regulatory requirements. The successful candidate should be willing to actively engage and contribute their technical knowledge, to aid the progression of portfolio development, bringing relevant products to successful manufacture and commercialisation.

• Work closely with the QARA Manager and Team Leader, maintaining compliance with applicable ISO Quality standards (ISO13485 and ISO9001) and the regulatory and statutory requirements of the IVDR, necessary for the continued business activities of the Mast Group Limited.
• Investigation into complaints received, ensuring corrective action and preventive measures are identified, documented and actioned, in line with QMS requirements.
• Involvement in all other QMS requirements, including Internal audits, document control, Qualification and Validation projects, change control, Supplier approval, monitoring and re-evaluation,
• Oversee and maintain portals for training records and equipment calibration records.
• Work with R&D staff in the compilation/storage and accessibility of product technical documentation in accordance with applicable regulatory requirements (IVDR / UKCA).
• Ensure Mast products are registered in accordance with relevant national requirements for UK and also for Global use, as required.
• Provide advice/guidance to departments in regulatory matters.
• Create relevant paperwork required to support global shipment of manufactured product.
• Investigate and action ad-hoc global regulatory enquiries and provide necessary documentation.
• Preparation of written reports and documentation.
  In addition to the specified duties the Quality Assurance and Regulatory Affairs Specialist is expected to perform additional tasks that the company may require.