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For Companies At a Glance
- Tasks: Manage regulatory processes and technical documentation for innovative medical devices.
- Company: Established medical device manufacturer with a strong growth trajectory.
- Benefits: Hybrid working, ownership of projects, and clear career progression.
- Why this job: Make a real impact in a close-knit team while shaping regulatory practices.
- Qualifications: 4+ years in Medical Device regulations and a proactive attitude.
- Other info: Enjoy autonomy in a dynamic environment with exciting new product developments.
The predicted salary is between 36000 - 60000 £ per year.
If you’re tired of being boxed into a tiny corner of Regulatory Affairs, this is the role that finally gives you the ability to work across it all.
A long established Medical Device manufacturer (40+ years in business) is growing fast and looking for a Regulatory Specialist who wants ownership, variety, and the chance to shape how things are done as they scale across Europe.
What’s in it for you
- Ownership of meaningful end to end regulatory work
- A company already MDR certified with zero audit findings
- Exciting new product development coming through the pipeline
- Real influence over technical documentation, processes and compliance direction
- Hybrid working with flexibility (2 to 3 days onsite)
- Clear progression and development opportunities as the business scales
- Stability and backing from a global group, without losing the small company feel
What you’ll be working on
- MDR maintenance across the product range
- Building and updating technical files from scratch
- Supporting new product development and EU expansion projects
- Contributing to biocompatibility inputs & CER updates
- Managing global registrations and renewals (EU focus, plus ROW exposure)
- Leading PMS activities, product review meetings and contributing to complaints decisions
- Handling vigilance/recall actions, ensuring timelines and reporting requirements are met
What they’re looking for
Someone who enjoys autonomy, likes getting stuck into all aspects of regulatory and is confident in their ability. This isn’t a position where you will be hand held. They’re looking for someone to come in and know the landscape well enough to hold your own.
If you’ve ever felt like a tiny cog in a giant RA team, you won’t here. This is a small, close knit environment where everyone knows each other and your work actually matters.
To be considered, you must:
- Be UK based with the right to work in the UK
- Be happy to be onsite 2 to 3 days per week
- Have experience working within Medical Device regulations (4+ years)
Please submit your CV if you’d like to be considered.
Senior Regulatory and Technical File Specialist employer: Medibeam
Contact Detail:
Medibeam Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Regulatory and Technical File Specialist
✨Tip Number 1
Network like a pro! Reach out to your connections in the medical device industry and let them know you're on the hunt for a Senior Regulatory Specialist role. You never know who might have the inside scoop on openings or can put in a good word for you.
✨Tip Number 2
Prepare for those interviews by brushing up on your knowledge of MDR regulations and technical file management. We want you to feel confident discussing your experience and how it aligns with the company's needs. Practice makes perfect!
✨Tip Number 3
Showcase your autonomy! When chatting with potential employers, highlight instances where you've taken ownership of projects or processes. They’re looking for someone who can hit the ground running, so let them know you’re that person.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, we love seeing candidates who are proactive about their job search.
We think you need these skills to ace Senior Regulatory and Technical File Specialist
Some tips for your application 🫡
Tailor Your CV: Make sure your CV reflects the specific skills and experiences that match the Senior Regulatory Specialist role. Highlight your experience with Medical Device regulations and any relevant projects you've worked on.
Craft a Compelling Cover Letter: Use your cover letter to showcase your passion for regulatory affairs and how you can bring value to our team. Mention why you're excited about the opportunity to work in a close-knit environment where your contributions truly matter.
Showcase Your Autonomy: Since this role requires someone who enjoys autonomy, be sure to include examples of when you've taken ownership of projects or processes in your previous roles. We want to see that you can hold your own in a dynamic environment!
Apply Through Our Website: For the best chance of being considered, make sure to apply directly through our website. This helps us keep track of your application and ensures it gets to the right people quickly!
How to prepare for a job interview at Medibeam
✨Know Your Regulations
Make sure you brush up on the latest Medical Device regulations, especially MDR. Being able to discuss specific regulations and how they apply to the role will show that you're not just familiar with the basics but are ready to take ownership of the regulatory work.
✨Showcase Your Autonomy
This role requires someone who enjoys autonomy and can handle various aspects of regulatory affairs. Prepare examples from your past experiences where you've taken initiative or led projects independently. This will demonstrate that you can thrive in a small, close-knit environment.
✨Highlight Technical File Experience
Since you'll be building and updating technical files, come prepared to discuss your experience in this area. Bring specific examples of technical documentation you've worked on, and be ready to explain your approach to ensuring compliance and accuracy.
✨Ask Insightful Questions
Prepare thoughtful questions about the company's current projects, their approach to new product development, and how they handle global registrations. This shows your genuine interest in the role and helps you gauge if the company culture aligns with your values.
