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:
- 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.
#J-18808-Ljbffr