Careers at Clinisupplies

Regulatory Affairs Administrator

Harrow

Reporting to: Regulatory Affairs Manager

Department: Regulatory

Location: Harrow

Contract type: Permanent

Company Information

Established in 2000, Clinisupplies is a UK based medical devices company specialising in the manufacturing and marketing of products for the primary and secondary healthcare sectors.

Mission

To enhance quality of life and provide peace of mind

Vision

To establish a global footprint in healthcare by 2020, enabling our innovations to benefit people today and in the future

Values

  • Passion – to strive to better understand people’s needs
  • Respect – to always act with honesty and integrity
  • Ambition – to innovate and make real change in healthcare
  • Positive attitude – to have a positive attitude in all that we do

What do we stand for?

Same on outcomes. Better on price

At Clinisupplies, we want to make a difference in healthcare. That means understanding our customers’ needs and delivering on their biggest priorities. We recognise that the NHS needs to offer quality of care and save money – that’s why Clinisupplies offers products that are designed to deliver value to customers. With a strong focus on Urology, Wound & Skin care, and Wound Closure, our products and services are developed to assist clinicians and patients, with practical solutions that provide high quality outcomes at an exceptional price.

Role summary

We are looking for a motivated and enthusiastic individual who is looking to develop a career within regulatory affairs. You will be responsible for supporting our Quality Management System and working with the team and wider business in preparation of technical files to support product submissions.

Key Responsibilities

  • To ensure appropriate regulatory compliance of medical devices in order to control the safety and efficacy of products
  • Maintain the Quality Management System as per ISO13485 at Clinisupplies, and at other group sites as required, to support certifications
  • Prepare, update and co-ordinate documentation (Standard Operating Processes (SOP), forms and instructions) maintaining them to maintain our quality systems
  • Assist the Regulatory Affairs Manager during regulatory inspections
  • Liaise with colleagues and suppliers on regulatory matters in the launch of new product lines
  • Manage customer complaints ensuring all complaints and non-compliances are dealt with in accordance with company procedure and Medicines and Healthcare products Regulatory Agency (MHRA) guidelines, while maintaining Corrective and Preventive Actions (CAPA) and satisfactory closure
  • Support new product development (NPD) activities ensuring any regulatory requirements are completed
  • Ensure all relevant storage temperature records are reviewed regularly and the necessary records are kept as required for internal and external audits for Clinisupplies and its subsidiaries
  • Check conformity documents as per the required standards
  • Assist the Regulatory Affairs Manager with any other duties as required from time to time

Experienced Required

  • Science degree
  • Working knowledge of regulatory affairs
  • Microsoft Office - Excel at intermediate level
  • Strong administration skills and attention to detail
  • Excellent organisational skills
  • Good communication skills
  • Good written English

Desirable

  • Regulatory qualification or experience
  • Auditing skills

Clinisupplies is dedicated to the continuous development of our employees and offer excellent career prospects for the strong candidate. We offer an attractive benefits package including a competitive salary, 27 days holiday pro-rata (increasing with service) plus bank holidays, pension, profit related pay.

Clinisupplies Limited is an equal opportunities employer and positively encourages applications from suitably qualified and eligible candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity.

How to apply

If you are interested in this position, please forward your CV to recruitment@clinisupplies.co.uk

Please note that in addition to the interviews there will be assessments as part of our recruitment and selection process.