Regulatory Officer, SR5

The Organisation is a leading and well-established medical diagnostic company, with an international reputation comprising two flagship business divisions that specialise in the design, manufacture and support of Clinical Electrophoresis and Haemostasis systems. We are currently recuriting for a vacancy within the QA Department. Reporting to the Person Responsible for Regulatory Compliance (PRRC) your primary responsibility would be to ensure master product documentation is available in a timely manor as directed by the production plan and to assist with ensuring that the company is Audit ready at all times. Main Duties and Responsibilities: - To act as an approver of production documentation and associated artwork/documentation used by the end customer and for internal use, and to make the documents effective, where outside Q-Pulse if required. - To act as an approver of site and departmental standard operating procedures, and to raise new procedures where necessary. - To manage and facilitate with all global registration related activities, including producing country specific documents where required and acting as signatory on behalf of the company. - To assist with the maintenance of the site Quality Management System, including updating of documentation and providing training where necessary, including site induction training. - To participate in the preparation of Safety Data Sheets and/or act as an approver of Safety Data Sheets and associated documentation and advise on Dangerous Goods Transport. - To maintain interfaces with MHRA website for certificates of free sale. - To maintain licence requirements with Home Office. - Regular review and company notification of regulatory legislation and guidelines, other than IVDR 2017/746. - To carry out other duties as directed by the Technical Director or CEO, commensurate with the position and status. Experience - Knowledge and experience of Quality Management Systems e.g. ISO9001, ISO 13485 and the US Quality System Regulation. - Knowledge and experience in regulatory requirements according to ISO 13485, IVDD (98/79/EC), IVDR 2017/746 and FDA Quality Systems Regulation. - Sound working knowledge of Good Manufacturing Practices, including personnel training skills. - Design and preparation of Standard Operating Procedures. - Sound working knowledge of Safety Data Sheet requirements. - Review and approval of compliance of company production and QC documentation