Reagents Compliance Manager

This vacancy is not eligible for Visa Sponsorship. Please do not apply unless you have another means of establishing a right to work, or you are already employed by the NHS and would transfer to the pay point above the base of a Band 7.
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 NHSBT's 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 You
Experience and Knowledge

• Well developed specialist knowledge in reagents production and regulatory compliance
• Experience of working in a highly regulated environment, relevant to diagnostic services including in depth knowledge of standards and guidelines affecting laboratory practice and reagents production
• Skilled in audit, validation of equipment, processes, research and development activity
• Experience of working with Information Technology using Microsoft Office packages (Word, Excel and PowerPoint) and databases
• In depth understanding of NHSBT and wider healthcare community

Qualifications And Training

• HCPC professional registration required (which must be maintained in the role)
• First Level Sciences degree
• Willingness to work towards and complete MSc or FIMBS within 3 years of registering on the course
• Post HCPC registration qualification
• Demonstrate commitment to and evidence of own Continued Professional Development (CPD).

About Us
It takes all types of people to deliver the kind of service that saves and improves lives. At NHS Blood and Transplant, you'll 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.

What We Offer

• NHSBT promotes flexible working opportunities where the role will allow.
• 27 days annual leave (pro rata for part-time) plus Bank Holidays, increasing to 29 days after 5 years' service and to 33 days after 10 years.
• NHS pension scheme. The NHS Pension Scheme is a defined benefit scheme (not dependent on investment returns) Further details and outline of benefits can be found at:
• We've fostered a culture of continuous learning where colleagues are well-led, engaged, and encouraged to grow. We support you in reaching your full potential, both in your current role and future career. Our Thrive program embodies our commitment to learning and development, offering a wide range of activities to support your personal and professional growth. It's open to everyone at NHSBT, ensuring you have the resources to succeed and shine in your role.

To learn more, please see our recruitment profile, which provides a summary of the job description and person specification. This can be accessed via the link below, or by clicking 'Apply' if you are viewing this advert on another site.

This vacancy will close at 23:59 on Wednesday 17 December 2025.

Interviews are anticipated to be held on 6 January 2026 subject to confirmation

For informal enquiries please contact Michelle Weston - RCI National Reagents Manager/PDPU Operations Manager, via email