Regulatory Affairs Manager
Who we are: The Rosalind Franklin Laboratory (RFL) is publicly owned and operated by the UK Health Security Agency (UKHSA) and is at the heart of the UK’s response to managing the coronavirus (COVID-19) pandemic.
RFL is the largest facility of its kind in the UK, and one of the largest in Europe. Using cutting-edge technology, the lab has processed millions of PCR tests since opening in June 2021. The lab continues to play a vital role in stopping the transmission of COVID-19, as well as ensuring the nation can respond quickly and at greater scale to deal with pandemics and other future health threats.
This world-class facility has considerable benefits to the local area in terms of job creation and putting Royal Leamington Spa on the international scientific map, while contributing to the UK’s ambition to be a global leader in science, medicine and technology.
In this role you will have the opportunity to: be a part of a dynamic and forward-thinking team whose role has significant importance to the success of the accredited service offerings by the Rosalind Franklin Laboratory. You will be involved in the development and implementation of industry leading best-practice processes and gain continuous professional development relevant to the role you perform.
Overall responsibility for the implementation and maintenance of the library of Regulatory Standards, Guidelines and Approved Codes of Practice (ACOP)
Establishing, implementing and maintaining processes needed for the validation of methods, and qualifications, including reporting.
Promoting the awareness of regulatory and customer requirements throughout the organisation
Liaison with external parties on matters relating to the Regulatory requirements
Compilation of technical files, validation/verification/qualification reports, and regulatory submissions
To succeed in this role, you should have the following skills & experience:
· Strong regulatory knowledge – coming from and working in a regulatory environment
· Full understanding of the safe operation of all laboratory equipment
· Proven knowledge of systems in the laboratory for the storing and reporting of analytical data and results
· Knowledge and experience of scientific equipment is essential
· Strong understanding of ISO9001
Education: Science Degree as a minimum
In return we offer you: You will receive a minimum 18-month contract with opportunity to go permanent and competitive rate of pay £51,519.
Working hours: Monday – Friday 9:00am – 5:00pm
If you would like to request any reasonable adjustments around start times, working additional hours, learning about different shifts or future opportunities around securing a permanent position, please speak to the team to learn more about how we can accommodate you.
Compliance: Please be aware that Baseline Personnel Security Standard (BPSS) including a media check is the required level of screening for all staff working at the Leamington Spa Laboratory.
Diversity: You will be joining a diverse and hugely welcoming team that reflects the communities we serve. We aim to foster a culture where individuals of all backgrounds feel confident in bringing their whole selves to work, feel included and empowering them to contribute fully at work.
If you're ready for a new challenge and want to be part of the team delivering this essential lab work, please apply today.
Please note: Impellam Group is working in partnership with NHS Test and Trace, so you will be employed on a fixed-term employment basis with an Employing Agency (either SRG, Medacs, Lorien or Blue Arrow) within Impellam Group, in line with contractual employment terms and conditions set out by the respective Employing Agency, and not directly employed by NHS Test and Trace.