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Staff Changes in Quality and Regulatory Department

By Ellie Nixon | 14th July 2021

Hart has recently had some changes in staff in the Quality and Regulatory departments over the last few weeks.

Firstly, after creating the new position of Regulatory Affairs Officer, Claire Reinhard has applied internally and she has been accepted into this newly created role.

Claire said: “I am absolutely over the moon with my new career as a Regulatory Affairs Officer, supporting my manager Jenny Leach within the new Hart Biologicals Regulatory Affairs department, as it is a field I have wanted to move into for some time. I have worked in the same company as Jenny for years but did not have the opportunity to work closely with her until now

I am very happy to have her supporting me and feel very excited about the future of this department and the direction it will take. I will have a very varied job, some of the responsibilities I will have include ensuring Hart Biologicals continues its compliance with all relevant standards relating to our products and markets by gathering and evaluating information relating to this and liaising with governing regulatory bodies

I shall be drawing upon my substantial scientific background from working in industry within Quality Control and my academic projects to study scientific documentation as well as legal documents, product trial results, labelling requirements and IFU information relating to our products, in addition to various documents in conjunction with other departments that we will be working closely with. I will be assisting Jenny in co-ordinating and participating in Regulatory inspections as well as helping deal with customer information requests connected to product registrations.”

We have externally found a new Quality Manager, Petra Elischer who has excellent experience with In-Vitro-Diagnostics and has also worked as both a Quality Manager focusing on QA roles and as a Quality Control laboratory lead.

Petra said: "I have started with Hart Bio just 3 days ago and the gut feeling which brought me here is still there, I am very excited I could be a part of the Hart Bio Family. My role as QA Manager is even more exciting because there is a great number of changes in the Quality department which has recently happened as a promotion of Kelly Ward into her new position as QA Supervisor, Claire Reinhard who has recently moved from QC to Regulatory Affairs department and my appointment as a QA Manager

Even more changes are in front of us which will require great amount of work and effort to get on track with the changes in the field of IVD standards and regulations, because of the EU IVDR 2017/746 as well as the requirements of the UK regulations for IVD devices and change of ISO 13485 which is currently under review and should be released in new version either by the end of this year or early 2022

There is really lot of things coming our way and we need to be ready for it the best we can, and I feel quite confident that Hart Bio is one of the companies which can make it through this storm of changes."

Kelly Ward will become our Quality Assurance supervisor and she will be broadening her responsibilities aswell as helping our new Quality manager with her new position. Kelly has gained a lot of experience here at Hart over the last few years and will continue to do so.

Kelly said: "I am really happy and excited about my new role as QA Supervisor, it’s great to have been given the opportunity to advance within Hart Biologicals. I am looking forward to the new challenges that will come with the employment of our new Quality Manager Petra Elischer. I am confident with the new QA / regulatory team in place that we can support the growth that the company has planned. After a very difficult 18 months I am very much looking forward to the future and development of our department."

All these exciting new changes in staff will help us to prepare for all of the upcoming challenges with both new and existing projects.

Congratulations and good luck to all starting their new positions at Hart.

Go to our Careers page to view any available vaccanies.