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For Companies At a Glance
- Tasks: Ensure regulatory compliance and maintain technical documentation for medical devices.
- Company: Join Medasil Surgical, a leading UK medical device company with a focus on quality.
- Benefits: Competitive salary, career development, and a collaborative work environment.
- Why this job: Make a real impact in healthcare by supporting patient care globally.
- Qualifications: 3-5 years in Medical Device Regulatory Affairs and a relevant degree.
- Other info: Dynamic role with opportunities for growth in a respected company.
The predicted salary is between 40000 - 50000 £ per year.
About Us
Medasil Surgical Limited is a leading UK-based medical device company specialising in the design, manufacture, and supply of single-use surgical products. With a strong reputation for quality and customer focus, we are committed to delivering safe and effective solutions to healthcare professionals worldwide.
The Opportunity
We are looking for a Regulatory Affairs Associate to join our team in Leeds. This role offers the opportunity to play a key part in maintaining and enhancing regulatory compliance across our product portfolio in a fast-paced and collaborative environment. This is a Full-time position, mainly onsite with occasional flexible working possible.
Key Responsibilities
- Ensure compliance with all applicable medical device regulations, standards, and legislation
- Create, update, and maintain Technical Documentation and Technical Files
- Conduct regular reviews to ensure alignment with harmonised standards and regulatory requirements
- Perform regulatory gap analyses against new or updated standards
- Review and approve design changes, engineering updates, CAPA, and nonconformances for regulatory impact
- Monitor regulatory changes and support updates to SOPs and internal systems
- Manage and support product registrations with Competent Authorities (e.g., MHRA, EUDAMED)
- Ensure post-market surveillance activities are effectively integrated into Technical Documentation
- Review and approve labelling, promotional materials, and product claims
- Participate in internal and external audits
- Collaborate cross-functionally to support compliant product lifecycle management
- Responsible for delivering high-quality, audit-ready technical documentation
- Ensuring timely regulatory submissions and approvals
- Proactively identifying regulatory risks and recommending solutions
Skills & Experience
- Minimum 3 to 5 years’ experience in a Medical Device Regulatory Affairs role
- Bachelor’s degree in Science, Engineering, Regulatory Affairs, or related discipline
- Strong understanding of: MDD 93/42/EEC, MDR 2017/745, and UKCA requirements
- ISO 13485 Quality Management Systems
- Proven experience in: Creating and maintaining Technical Documentation, Conducting regulatory gap analyses, Interpreting and applying harmonised standards and regulatory guidance, Reviewing design changes, CAPA, and nonconformances, Post-market surveillance and Technical File maintenance
- Knowledge of risk management, clinical evaluation documentation, and labelling requirements
- Familiarity with device registration systems such as MHRA and EUDAMED
- Strong analytical, organisational, and communication skills
Why Join Medasil?
- Be part of a respected and growing medical device company
- Work within a collaborative and quality-driven environment
- Opportunity to contribute to products that support patient care globally
- Career development within Regulatory Affairs
- Competitive salary dependent on experience.
Medasil Surgical Limited is an equal-opportunity employer. We welcome applications from all qualified individuals regardless of background and identity.
If you are passionate about regulatory compliance and want to grow your career with Medasil Surgical Limited, we would love to hear from you.
Regulatory Affairs Associate in Leeds employer: MEDASIL SURGICAL LIMITED
Contact Detail:
MEDASIL SURGICAL LIMITED Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Associate in Leeds
✨Tip Number 1
Network like a pro! Reach out to current or former employees at Medasil Surgical Limited on LinkedIn. A friendly chat can give us insider info about the company culture and maybe even a referral!
✨Tip Number 2
Prepare for the interview by brushing up on your knowledge of MDD, MDR, and UKCA requirements. We want to show that we’re not just familiar with the regulations but can also apply them in real-world scenarios.
✨Tip Number 3
Practice common interview questions related to regulatory affairs. Think about how you’ve handled compliance issues in the past. We need to demonstrate our problem-solving skills and attention to detail!
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, it shows that we’re genuinely interested in joining the Medasil team.
We think you need these skills to ace Regulatory Affairs Associate in Leeds
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Regulatory Affairs Associate role. Highlight your experience with medical device regulations and any relevant qualifications. 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 compliance and how you can contribute to our team. Keep it concise but impactful – we love a good story!
Showcase Relevant Experience: When filling out your application, be sure to showcase your experience with Technical Documentation and regulatory gap analyses. We’re keen on seeing how you've tackled similar challenges in the past!
Apply Through Our Website: Don’t forget to apply 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 a few clicks and you’re done!
How to prepare for a job interview at MEDASIL SURGICAL LIMITED
✨Know Your Regulations
Make sure you brush up on the key regulations like MDD 93/42/EEC, MDR 2017/745, and UKCA requirements. Being able to discuss these confidently will show that you’re not just familiar with the basics but are ready to dive into the specifics of the role.
✨Showcase Your Documentation Skills
Prepare examples of your experience in creating and maintaining Technical Documentation. Bring along samples or be ready to discuss how you've handled regulatory gap analyses and post-market surveillance activities in your previous roles.
✨Be Ready for Scenario Questions
Expect questions that ask how you would handle specific regulatory challenges or changes. Think about past experiences where you identified regulatory risks and how you proposed solutions. This will demonstrate your proactive approach and problem-solving skills.
✨Highlight Cross-Functional Collaboration
Since the role involves working with various teams, be prepared to discuss how you’ve collaborated with other departments in the past. Share examples of how you’ve supported compliant product lifecycle management and contributed to audit-ready documentation.