Regulatory Compliance Officer

About the Organisation:
National Services Scotland (NSS) is a national NHS Board operating right at the heart of NHSScotland providing invaluable support and advice at a strategic and operational level. NSS supports customers to deliver their services more efficiently and effectively and we offer shared services on a national scale using best-in-class systems and standards. Our priority is always the same - to improve the health and well-being of the people of Scotland. We do this by working in partnership with colleagues across Health and Social Care to deliver fit for purpose solutions and systems, delivering high quality services that help our stakeholders to free up resources so they can be re-invested into essential services.

The core purpose of the Scottish National Blood Transfusion Service is to meet the transfusion needs of patients in Scotland. In support of this, we are committed to a range of programmes that will enhance the service provided to NHS Scotland in both clinical and operational areas.

The Post:
In support of SNBTS Quality and Regulatory Compliance develops and delivers a Quality Management System throughout SNBTS, which ensures compliant, high quality, efficient processes from donor to patient. Regulatory Compliance sits as a key function within this department, with a view to delivering regulatory compliance and progression of key projects from a regulatory point of view including regulatory submissions for SNBTS.

SNBTS undertakes activity regulated by several regulators and accreditation bodies which include (but are not limited to the MHRA; Blood Establishment, Advanced Therapy Medicinal Products (MIA(IMP), MIA, Manufacturing Specials) and Wholesale Dealing, Human Tissue Authority, HFEA, UKAS and JACIE. Licensing and accreditation is essential to enable SNBTS to continue to supply blood, tissues, cells and Advanced Therapy Medicinal Products.

As a result, SNBTS operates within an increasingly complex and diverse regulatory framework. It is the role of the Regulatory Compliance team to navigate relevant regulations, guidance and standards to facilitate awareness, compliance and to deliver regulatory submissions in support of SNBTS projects and strategies. Regulatory Compliance Officers are a key member of this team.

The post holder will be required to be forward thinking and imaginative with the drive and self motivation to deliver regulatory submissions to achieve approvals to support the SNBTS strategy including, Preparation Process Dossiers to the HTA, Clinical Trial Applications including writing of IMPDs (for the most part Quality Section) to the MHRA, as well as providing regulatory support and guidance across all of SNBTS activity.

The post holder will be a member of a small team which is expanding as a result of increase in Regulatory Compliance support for the Tissues Cells and Advanced Therapeutic projects in the delivery of Advanced Therapy Medicinal Products. This is an exciting opportunity to be part of this team.

The Candidate:
Applicants for this Post should hold a Degree in a scientific, biomedical or other relevant subject and have experience of working to the requirements of a Quality Management System in a regulated environment such as Transfusion Service delivery or commercial pharmaceutical or device manufacture. The applicant should have awareness of the regulatory framework mentioned above. Direct experience in the preparation of regulatory submissions will be an advantage.

The successful candidate will be required to undergo a PVG Scheme/Disclosure Scotland check. Any candidate who have lived/worked overseas for more than 12 months in the preceding 5 years will also be required to provide a criminal record check from the appropriate overseas agency.

Location and Working Pattern:
This post will be based at the SNBTS Jack Copland Centre, Edinburgh.

Monday to Friday, 37 hours per week

It is a condition of this employment that you must live and remain a resident within the UK for the post in which you will be employed with NSS.

Benefits:
Our benefits package includes pension scheme, comprehensive range of work life balance policies, occupational health services, learning resource centres and discounted leisure, financial and shopping benefits. HR Benefits Brochure.

Inclusion:
NHS National Services Scotland (NSS) is a national board and, as an anchor institution, it is our ambition to be a diverse and inclusive organisation where everyone feels welcome. We recognise that flexible working creates an inclusive workplace where employees can thrive and feel confident about their ability to balance their personal and professional responsibilities. This is supported through Once for Scotland flexible working policies. NSS has made a long-term commitment to staff health and well-being and offers many learning and development opportunities to support and improve our approaches to diversity, inclusion and mental health in the workplace. There are a number of equality staff networks in place which all staff are welcome to join. We are also an equal opportunities employer and as such guarantee to interview all disabled applicants who meet the minimum criteria for our vacancies. As an accredited Disability Confident Leader, it is the aim of NSS to offer a fully accessible and inclusive recruitment service that supports applicants on their candidate journey. If you are interested in any reasonable adjustments, please contact the Recruitment Team on

Further information:
For an informal discussion on the post, please contact Emily Hargreaves Regulatory Compliance Manager, or

Closing date for completed applications is Wednesday 23rd July

Further information on NSS is available from:

Please note that the majority of correspondence is sent by e-mail only, so please check your e-mail regularly (including junk folders).

NHS National Services Scotland is an equal opportunities employer and as committed participant in the disability confident scheme, guarantees to interview all disabled applicants who meet the minimum criteria for our vacancies