RA Specialist

GXPeople are looking for a RA Specialist to join a Medical Device SME client on full time & hybrid basis.

The role will be part of a experienced QARA team. You will be responsible for writing technical file documentation and providing regulatory support in maintaining and updating Medical Device Technical files compliant with MDR/IVDR. In addition, you will also lead in delivering the Post Market Surveillance strategy and reports and have the ability to manage multiple regulatory projects.

About the Role:

• Responsible for leading the successful implementation of UDI (Unique Device Identifier) for CE and UKCA marked devices independently.


• Responsible for independently writing UKCA and CE compliant technical files and DHF documents, ensuring compliance with industry standards to ISO 13485


• Assess device changes and impact on Technical Files, ensuring Change Control process is followed for technical file revisions.


• Subject matter expert for the review and development of product packaging, product labelling, product claims and promotional items to ensure all applicable regulatory requirements have been met i.e. ISO 15223, IVDR, ISO 13485 requirements.


• Laise with regulatory authorities during the development and review process for CE marking to ensure submission approval.


• Support handling CAPAs to implement corrective and preventative actions.


• Provide regulatory input to support the resolution of manufacturing issues with fulfilment and ensure these actions are documented using the QMS framework.


• Support internal and third-party audits when needed.

Skills and Experience:

• Ideally 2-3 year of working with in a RA team in a medical device or IVD manufacturer.


• Experience in writing technical files, design history file documents and knowledge of the STED.


• A proven ability to plan, coordinate and manage multi-disciplinary projects, i.e. CE marking devices alongside day-to-day RA tasks.


• Experience with writing technical files, design history file documents and knowledge of the STED format.


• Ideally Degree Qualified- Preferably a scientific or relevant subject.

If you feel like this role is suitable and would like to find out more please apply to this advert with your most recent CV.