Mark this as favouriteSenior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist

Salary: £80.00 ph

Mon - Fri - 37.5 hours

12-month contract

Hybrid/Remote - must be able to travel to Warrington

Gi Group is proud to be partnering with a global leader in the life sciences sector, currently seeking a Senior Regulatory Affairs Specialist to join their EMEA Regulatory Affairs team on a 12-month contract.

This is an excellent opportunity for an experienced regulatory professional with a background in IVD or medical devices, looking to work in a dynamic, international environment. You will play a key role in supporting regulatory submissions and ensuring compliance for performance studies across the EU.

THE ROLE:

As a Senior Regulatory Affairs Specialist, your responsibilities will include:

* Leading EU Member State notification activities for IVDR performance studies, particularly those involving leftover samples

* Preparing, reviewing, and submitting regulatory documentation to Competent Authorities and Ethics Committees

* Acting as the main point of contact for regulatory bodies, managing queries and requests for additional information

* Collaborating cross-functionally with Clinical, Medical, Legal, Quality, and Project Management teams

* Ensuring all submissions are accurate, compliant, and delivered within required timelines

* Maintaining clear and audit-ready documentation in line with internal quality systems

* Providing regulatory guidance to project teams, supporting study design and submission strategy

* Managing multiple regulatory projects across different EU countries simultaneously

THE CANDIDATE:

* Degree in Life Sciences, Biomedical Sciences, or a related discipline

* Minimum 3 years' experience in Regulatory Affairs or Clinical Regulatory within IVD, medical devices, or pharmaceutical industry

* Strong knowledge of EU regulatory frameworks, particularly IVDR (EU 2017/746)

* Proven experience with regulatory submissions and interactions with Competent Authorities and/or Ethics Committees

* Excellent organisational and project management skills

* Strong written and verbal communication skills in English

* Ability to work independently within a matrix organisation and manage competing priorities

* Comfortable working in a fast-paced, international environment

* Willingness to travel occasionally (approx. 10-15%)

* A Basic DBS check is required for this role

This is a fantastic opportunity to join a forward-thinking organisation at the forefront of life sciences innovation, offering a collaborative culture, flexible working, and the potential for extension.

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Should you require any support or assistance, please contact your local Gi Group office.

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Gi Group Holdings Recruitment Limited group of companies includes Gi Recruitment Limited, Draefern Limited, Gi Group Recruitment Ltd, INTOO (UK) Limited, Marks Sattin (UK) Limited, TACK TMI UK Limited, Grafton Professional Staffing Limited, Encore Personnel Services, Gi Group Ireland Limited and Kelly Services (UK) Ltd. Gi Group Ireland Limited are acting as an Employment Agency in relation to this role.

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