Senior Regulatory Affairs Specialist - Medical Devices
Leeds | Full Time | Primarily Onsite
Ready to make a real impact in Regulatory Affairs?
At Medasil Surgical Ltd, we manufacture and supply high-quality single-use medical devices used by healthcare professionals around the world. As our business continues to grow, we're looking for an experienced Senior Regulatory Affairs Specialist to help shape and maintain the regulatory compliance of our product portfolio.
This isn't just another Regulatory Affairs role. You'll have the opportunity to influence projects from concept through to post-market surveillance, work alongside experienced Quality and Engineering professionals, and play a key role in ensuring our products continue to meet the highest regulatory standards.
If you're passionate about compliance, enjoy solving complex regulatory challenges and want to work in a business where your expertise genuinely makes a difference, we'd love to hear from you.
The Role
As our Senior Regulatory Affairs Specialist, you'll be responsible for ensuring our medical devices remain compliant with UK and European regulatory requirements while supporting the ongoing development of our Quality Management System.
You'll be involved in:
- Creating, reviewing and maintaining Technical Documentation and Technical Files
- Ensuring compliance with MDR 2017/745, MDD 93/42/EEC, UKCA and other applicable regulations
- Conducting regulatory gap analyses and implementing improvements
- Reviewing design changes, CAPAs, engineering changes and non-conformances for regulatory impact
- Supporting product registrations with MHRA, EUDAMED and other Competent Authorities
- Integrating post-market surveillance activities into Technical Documentation
- Reviewing labelling, IFUs, promotional materials and product claims
- Monitoring changes in legislation and supporting updates across the business
- Participating in internal and external audits
- Working closely with Engineering, Production and Quality teams to ensure regulatory compliance throughout the product lifecycle
Who We're Looking For
We're looking for someone who enjoys taking ownership and thrives in a collaborative environment.
You'll be the type of person who:
- Enjoys interpreting regulations and turning them into practical business solutions.
- Has exceptional attention to detail and takes pride in producing accurate, audit-ready documentation.
- Is naturally organised and able to manage multiple priorities.
- Can confidently communicate with colleagues across Quality, Engineering and Manufacturing.
- Likes solving problems and identifying regulatory risks before they become issues.
- Wants to contribute ideas and continuously improve regulatory processes rather than simply maintaining them.
What You'll Bring
You'll ideally have:
- A minimum of 5 years' Regulatory Affairs experience within the medical device industry.
- A degree in Science, Engineering, Regulatory Affairs or a related discipline.
- Excellent knowledge of:
- MDR (EU) 2017/745
- MDD 93/42/EEC
- UKCA Regulations
- ISO 13485
- Proven experience creating and maintaining Technical Documentation and Technical Files.
- Experience with regulatory gap analyses and interpreting harmonised standards.
- Knowledge of design controls, CAPA, post-market surveillance and risk management.
- Experience with MHRA and EUDAMED registrations.
- Excellent written and verbal communication skills.
Why Join Medasil?
We're proud of the products we manufacture and the people who make them possible. Joining Medasil means becoming part of a supportive team where quality, collaboration and continuous improvement are at the heart of everything we do.
We offer:
- Competitive salary based on experience
- A stable and growing UK medical device manufacturer
- A collaborative and supportive working environment
- Opportunities for professional development and career progression
- The chance to work on products that improve patient care around the world
Interested?
If you're an experienced Regulatory Affairs professional looking for a role where your knowledge will be valued and your work will have a genuine impact, we'd love to hear from you.
Apply today and become part of Medasil Surgical Ltd.
