Job Title: Quality & Regulatory Officer
PredictImmune was created in early 2017 as a spin-out from the Department of Medicine, University of Cambridge UK.
It is a new generation molecular diagnostics company offering a unique approach for the prognosis of immune-mediated diseases such as Inflammatory Bowel Disease, Lupus, Multiple Sclerosis etc. with a mission of “enabling better treatment and outcomes for patients with chronic immune mediated diseases”.
PredictImmune has developed and is launching its first prognostic test that is simple, robust and based on RT-PCR with a unique software algorithm for identification of patients with a high or low risk of disease progression in the next 12-18 months, using whole blood samples for use in routine in clinical laboratories. We are the first company to offer predictive tests in Inflammatory Bowel Disease and aim to develop tests for other immune-mediated diseases which will facilitate personalised treatment and thereby improve patient outcomes and health economics.
PredictImmune will provide its proprietary technology as both a laboratory service and as a kit depending on the needs of global markets. Currently PredictImmune has built a strong internal development and commercialisation team to creatively develop, validate and bring to market these unique and proprietary Prognostic tests via strategic partnering models throughout the world, while carrying out partnerships with a number of key Pharma companies in the Immunology sector on patient stratification and clinical studies. This will involve appointing an exclusive central lab partner in each region to perform and sell the test, while we support and influence regulators in major regions.
We are currently seeking an organised and methodical Quality & Regulatory Officer to join our vibrant team. You will be supporting the Head of Quality and Regulatory whilst working in close collaboration across the entire company, strong communication skills are therefore essential.
Objectives of the role:
- Support the product life cycle of IVD’s with regards to all quality and regulatory matters under the direction of the Head of Quality and Regulatory;
- Day to day management of key areas of the Quality Management System;
- Support in the preparation, maintenance and review of IVD product technical files;
- Support in the implementation of the company’s regulatory compliance strategy and development of new products;
- Be a key player in driving continuous improvement of the company’s QMS.
- Maintain and organise the company’s Quality Management System- Document control, change controls, Non-conformances (including complaints) Internal audit program, Maintenance and calibrations, Supplier Management etc.;
- Support the Head of Quality and Regulatory in ensuring that company products comply with regulations in all registered territories;
- Help collect, collate and evaluate scientific data from a range of sources;
- Support in the preparation of IVD technical files;
- Support during regulatory/customer inspections;
- Working with the team to ensure timely support with regards to all QMS processes.
The following skills/experiences are a requirement:
- Educated to degree level in Life Sciences or equivalent. The need for the qualification may be substituted for substantial hands on experience in Quality and Regulatory
- At least 2 years working experience in Quality Assurance and/or Regulatory affair role for a medical device manufacturer selling to the EU market
- Demonstrate a clear understanding of ISO 13485:2016 and the directives/regulations for CE marking
- Excellent organisational skills – able to manage multiple tasks to deadlines, think on your feet to solve problems and maintain a high level of accuracy, even in a changeable work environment
- Good numeracy, literacy and IT skills (i.e. Microsoft Office and able to learn new systems quickly)
- Strong communication and interpersonal skills (in written and spoken English), able to relate to colleagues and customers at all levels and navigate cultural differences with ease
What you’ll get in return
This is an excellent opportunity to help successfully build PredictImmune’s pipeline of products from concept to completion and in return we offer a competitive salary package + benefits including Life Assurance, Healthcare, Pension and stock options.
If you feel you have got what it takes to join a vibrant and dynamic company, then we would love to hear from you. Please send your CV and covering letter to: email@example.com
NO AGENCIES PLEASE