QA/ RA Manager | £40,000 to £70,000 | Gateshead, UK

This prestigious, leading, and well-established medical diagnostic company comprises two flagship business divisions that specialise in the design, manufacture and continued support of Haemostasis systems and Clinical Electrophoresis equipment.

The QA/ RA Manager will be responsible for regulatory compliance of all products manufactured across both business divisions in the North-East. Furthermore, the QA/ RA Manager will be responsible for managing the QMS of the company to ensure all medical devices sold are compliant within local/ national regulations. You will also be responsible for the quality of the products and that this is managed throughout product development and the manufacturing process.

Key Duties will include:
• To meet IVDR and IVDD compliance and the ISO standard.
• To act as an approver of production documentation and associated artwork/documentation used by the end customer and for internal use
• 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 manage all Safety Data Sheets (MSDS) and advise on Dangerous Goods Transport.
• To work with the marketing and technical research teams to define product positioning and develop compliant marketing materials.
• Work closely with the Quality Manager to ensure product is released to the market only if quality and regulatory requirements are met
• To ensure the company is Audit ready at all times.

Key Skills required:
• At least 2 years’ experience and background in medical device or pharmaceutical regulatory affairs management.
• 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
• Design and preparation of Standard Operating Procedures.
• Clear attention to detail with regards existing and new documentation.

Tagged as: document management, electronic Quality Management, IVDD, ivdr, medical device regulations, QMS, Quality, Regulatory affairs