Reagents Compliance Manager

Job summary

As an experienced Biomedical Scientist with an eye for detail, you will assist in ensuring NHSBT Reagents continues to excel at meeting all regulatory requirements. You will be part of the team supplying CE marked products to hospitals and blood transfusion services in the UK. You will be responsible for the product release and management of medical device files including the collation and interpretation of information to ensure ongoing compliance. As an experienced Biomedical Scientist this will also include working alongside other Biomedical Scientists in generating results in the laboratory. You will have an opportunity to develop skills in specialised transfusion techniques, audit and compliance knowledge to assist in ensuring that information is available to customers and regulators. You will join an organisation with a commitment to our core purpose of improving and saving patient s lives and in staff development. You will contribute to developing and providing a high-quality service, that meets the varied needs of customers and ensures the safety and wellbeing of patients.

Main duties of the job

You will be working as part of the Reagents senior management team. Your responsibilities will include :- Ensuring that documents and practices in NHSBT Reagents comply with regulatory requirements including ISO13485, Good Manufacturing Practice, In Vitro Diagnostics Directive, and NHSBTs Quality Management system. Writing and maintaining the product medical device files to meet these requirements. Approving release of NHSBT Reagents products, following scrutiny of Batch Manufacturing Records, and sign lot specific certificates of conformance. Maintaining records of batch manufacture and release. Monitoring trends in Quality Indicators. Working with Quality Project Specialist(s) leading on IVDD compliance to achieve these objectives. Planning and conducting quality audits of NHSBT Reagents and Reagents related processes. You may be required to travel and spend time away from base, which will involve working irregular hours and overnight stays when required, with prior notice

About us

It takes all types of people to deliver the kind of service that saves and improves lives. At NHS Blood and Transplant, youll join a team of more than 6,000 people who are making a genuine difference to communities, families, friends, relatives and more across the UK. We play a unique and special role in the NHS by helping people do something extraordinary- donate blood, blood products, organs, tissues, or stem cells to save someone in need. Our three core values are what set us apart. They guide and inspire everything we do. By being caring, expertly meeting the needs of our patients and our people, and accepting nothing less than the best quality, we can do extraordinary work and help our people to do something extraordinary in their career, too. Three small words, one big difference - Caring, Expert and Quality. Together we'll save and improve more lives than ever. You will join us on our journey to create an inclusive workplace and aim to reflect the diverse communities we work with, and we positively encourage applications from all sectors of the community.