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- Tasks: Lead regulatory submissions and ensure compliance for performance studies across the EU.
- Company: Global leader in life sciences with a dynamic, collaborative culture.
- Benefits: Flexible working, potential for contract extension, and a chance to make an impact.
- Why this job: Join a forward-thinking team at the forefront of life sciences innovation.
- Qualifications: Degree in Life Sciences and 3+ years in Regulatory Affairs or Clinical Regulatory.
- Other info: Opportunity to work in a fast-paced international environment with travel.
The predicted salary is between 45000 - 55000 £ per year.
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.
Senior Regulatory Affairs Specialist in England employer: Gi Group
Contact Detail:
Gi Group Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Regulatory Affairs Specialist in England
✨Tip Number 1
Network like a pro! Reach out to your connections in the life sciences sector, especially those who are already in regulatory affairs. A friendly chat can lead to insider info about job openings or even a referral.
✨Tip Number 2
Prepare for interviews by brushing up on EU regulatory frameworks, particularly IVDR. We recommend creating a cheat sheet of key points and examples from your experience that showcase your expertise in regulatory submissions.
✨Tip Number 3
Don’t underestimate the power of follow-ups! After an interview, send a quick thank-you email to express your appreciation. It keeps you fresh in their minds and shows your enthusiasm for the role.
✨Tip Number 4
Apply through our website for the best chance at landing that Senior Regulatory Affairs Specialist role. We’re always on the lookout for passionate candidates, and applying directly can give you an edge!
We think you need these skills to ace Senior Regulatory Affairs Specialist in England
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Senior Regulatory Affairs Specialist role. Highlight your experience in IVD or medical devices and any relevant regulatory submissions you've handled. We want to see how your background aligns with what we're looking for!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about regulatory affairs and how your skills can contribute to our team. Keep it concise but impactful – we love a good story!
Showcase Your Communication Skills: Since this role involves liaising with various teams and regulatory bodies, make sure to demonstrate your strong written communication skills in your application. We appreciate clarity and professionalism, so keep that in mind when drafting your documents.
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it’s super easy – just follow the prompts and submit your materials!
How to prepare for a job interview at Gi Group
✨Know Your Regulations
Make sure you brush up on the EU regulatory frameworks, especially IVDR (EU 2017/746). Being able to discuss specific regulations and how they apply to your past experiences will show that you're not just familiar with the rules but can also navigate them effectively.
✨Showcase Your Project Management Skills
Prepare examples of how you've managed multiple regulatory projects simultaneously. Highlight your organisational skills and how you prioritised tasks to meet deadlines. This will demonstrate your ability to thrive in a fast-paced environment.
✨Communicate Clearly
Since you'll be acting as the main point of contact for regulatory bodies, practice articulating your thoughts clearly and concisely. Use mock interviews to refine your verbal communication skills, ensuring you can explain complex regulatory concepts in an understandable way.
✨Collaborate and Connect
Be ready to discuss how you've worked cross-functionally with teams like Clinical, Medical, and Quality. Share specific instances where collaboration led to successful outcomes, as this role requires strong teamwork and the ability to provide regulatory guidance across various departments.