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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