Regulatory Affairs Manager

Location Royal Leamington Spa
Discipline: Lab Management
Salary: ££51519 per annum + 10% retention bonus
Contact name: Brenda Moore

Job ref: RLS601_1636017718
Published: about 1 month ago

Fixed Term Contract

We're currently seeking a Regulatory Affairs Manager based in and around Leamington Spa to work within a state of the art, high output diagnostics laboratory environment as part of the UK's NHS Test and Trace programme, helping society's return to a more normal way of life.

Gain invaluable experience and exposure to some of the country's most highly skilled individuals in the scientific community and join a supportive environment where training and accreditation (where relevant) will be provided for this role.

What you can expect:

To provide support to the Compliance Director with respect to establishing, implementing and maintaining processes needed for the validation of methods, and qualifications.

What we're looking for:

  • Previous experience of working in the medical device field.

  • 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

In return:

You will receive a minimum 18-month contract with opportunity to go permanent and competitive rate of pay and a 10% retention bonus (paid at 9 and 18 months)

Working hours and shift times

The hours are Mon - Fri 9-5.30

Compliance checks
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 at NHS Test and Trace
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.