QA & Regulatory Administrator
Fortuna Healthcare was established just over 30 years ago in 1995 and remains an independent family-run distributor of medical products and chemist sundry lines to the UK independent pharmacy market. It is now the wholesale arm of Fortuna Group (London) Ltd, a successful healthcare services company based in Enfield, London.
The company has an exciting new opportunity to work in a QA/Regulatory role in which the successful applicant would form part of a very friendly and highly ambitious team within a fast moving and dynamic small business environment. A competitive salary together with a generous benefits package is available to the successful applicant.
JOB SPECIFICATION:
Job Title: QA & REGULATORY ADMINISTRATOR
Reporting to: DIRECTOR
Location: FORTUNA HEALTHCARE: UNITS 3-4 CROWN ROAD, NORTHGATE BUSINESS CENTRE, ENFIELD, LONDON EN1 1TG
Start Date: April 2026
Hours: 8.30am – 5.30pm > MONDAY – FRIDAY **Part-time role to be considered
Salary: Basic Salary £30K / Annual Bonus / Benefits Package
This is a new role based at the company’s head office and consists of the day-to-day involvement in the Quality Assurance and Regulatory activities of the business. The successful applicant would work in close co-ordination with the Management team and would incorporate the following key areas of responsibility:
JOB DESCRIPTION:
Quality Assurance (QA): Supervision of the company’s Quality Management System (QMS)
Documentation Management: Supervision of the company’s documentation, records and Standard Operating Procedures (SOPs) that are essential for regulatory dossiers
Compliance Monitoring: Supervision of changes in regulations to ensure that internal processes remain compliant with external requirements e.g. ISO standards/MHRA guidelines etc
Audit Support: Assistance in preparing for and conducting internal and external audits which is a key part of the regulatory affairs function
Product Compliance: Regulatory supervision of the company’s full range of products in respect of ongoing legislation with particular reference to UK MDR 2002 & EU MDR 2017/745
Medical Consultancy: Development of the company’s sale of medical consultancy services to both UK and non-UK companies with particular reference to UK-RP & EU-AR services
JOB SKILLS SET:
Applicants should be self-motivated, able to think strategically and identify ways of adapting to an evolving healthcare landscapeApplicants should be articulate with strong interpersonal and analytical skills for dealing with customers / suppliers / colleaguesApplicants should possess excellent administration and IT skills are desirableIf you feel that you would be successful in this role then please attach your CV, together with a covering letter with details of your current and expected package.
DISABILITY CONFIDENT: Please note that Fortuna Healthcare is committed to the employment, retention and development of employees with disabilities of any kind. Applications from all individuals are welcome.
DIVERSITY COMMITMENT: As part of our company’s ongoing efforts to reflect our diverse customer base we at Fortuna Healthcare are actively seeking to hire candidates from all backgrounds.