At a Glance
- Tasks: Ensure medical device compliance and maintain technical documentation for UK and international markets.
- Company: Join Medasil Surgical Limited, a leader in medical device regulatory affairs.
- Benefits: Competitive salary, career development opportunities, and flexible working options.
- Other info: Dynamic team environment with opportunities for growth and learning.
- Why this job: Make a real impact in healthcare by ensuring product safety and compliance.
- Qualifications: 5+ years in Medical Device Regulatory Affairs and strong knowledge of relevant regulations.
The predicted salary is between 45000 - 55000 £ per year.
Medasil Surgical Limited is currently recruiting for a Senior Regulatory Affairs Associate to join our Regulatory Affairs team based in Leeds. This is a full-time, onsite role supporting medical device compliance across UK and international markets.
Key Responsibilities
- Ensure compliance with applicable medical device regulations, standards, and legislation
- Create, update, and maintain Technical Documentation and Technical Files
- Conduct periodic reviews of documentation to ensure compliance with harmonised standards
- Perform regulatory gap analyses against new and updated regulations
- Review design changes, engineering updates, CAPA, and nonconformances for regulatory impact
- Support and maintain product registrations with Competent Authorities (e.g., MHRA, EUDAMED)
- Ensure post-market surveillance requirements are met and reflected in Technical Documentation
- Review product labelling, promotional materials, and claims for regulatory compliance
- Support audits (internal and external) and regulatory inspections
- Monitor regulatory changes and support updates to internal procedures and systems
- Responsible for delivering high-quality, audit-ready technical documentation
- Ensuring timely regulatory submissions and approvals
- Proactively identifying regulatory risks and recommending solutions
Requirements
- Minimum 5 years’ experience in Medical Device Regulatory Affairs
- Degree in Science, Engineering, Regulatory Affairs, or a related discipline
- Strong working knowledge of: MDD 93/42/EEC, MDR 2017/745, and UKCA requirements
- ISO 13485 Quality Management Systems
- Experience in:
- Technical Documentation and Technical File maintenance
- Regulatory gap analysis
- Applying harmonised standards and regulatory guidance
- Reviewing CAPA, nonconformances, and design changes
- Understanding of:
- Risk management documentation
- Clinical evaluation reports
- Labelling requirements
- Device registration systems (e.g., MHRA, EUDAMED)
- Strong written and verbal communication skills
- Good organisational skills and ability to manage multiple tasks
Desirable
- RAC certification or advanced degree in Regulatory Affairs
- Experience working within a regulated medical device environment
Benefits
- Competitive salary (dependent on experience)
- Career development and progression opportunities
Schedule: Monday to Friday. Full-time, mainly onsite with occasional flexible working.
Medasil Surgical Limited is an equal‑opportunity employer. We welcome applications from all qualified individuals regardless of background and identity.
If you meet the above criteria and are looking to develop your career in Regulatory Affairs with Medasil Surgical Limited, please apply with your CV.
Senior Regulatory Affairs Associate - Medical Devices in Bradford employer: MEDASIL SURGICAL LIMITED
Medasil Surgical Limited is an exceptional employer, offering a dynamic work environment in Leeds where innovation meets compliance in the medical device sector. With a strong commitment to employee growth, we provide career development opportunities and a supportive culture that values diversity and inclusion. Join us to be part of a team that not only ensures regulatory excellence but also fosters a collaborative atmosphere for meaningful contributions to healthcare.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Regulatory Affairs Associate - Medical Devices in Bradford
✨Tip Number 1
Network like a pro! Reach out to professionals in the Regulatory Affairs field on LinkedIn or at industry events. We can’t stress enough how valuable personal connections can be in landing that dream job.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of MDD, MDR, and UKCA requirements. We recommend creating a cheat sheet of key points to discuss, so you can impress the interviewers with your expertise.
✨Tip Number 3
Showcase your experience with Technical Documentation and regulatory compliance during interviews. We suggest using specific examples from your past roles to demonstrate your skills and how they align with the job requirements.
✨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, it shows you’re genuinely interested in joining our team at Medasil Surgical Limited.
We think you need these skills to ace Senior Regulatory Affairs Associate - Medical Devices in Bradford
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Senior 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!
Showcase Your Skills:In your application, emphasise your strong written and verbal communication skills. Since this role involves creating and maintaining technical documentation, we need to know you can communicate complex information clearly and effectively.
Be Specific About Experience:When detailing your experience, be specific about your work with MDD, MDR, and UKCA requirements. We love seeing concrete examples of how you've handled regulatory compliance and technical documentation in your previous roles.
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 shows you're keen on joining our team at Medasil Surgical Limited!
How to prepare for a job interview at MEDASIL SURGICAL LIMITED
✨Know Your Regulations Inside Out
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 them but can apply them in real-world scenarios.
✨Prepare Your Technical Documentation Examples
Have specific examples of your experience with Technical Documentation and Technical Files ready to share. This could include how you’ve conducted regulatory gap analyses or maintained compliance with harmonised standards. Real-life examples will make your answers more impactful.
✨Showcase Your Problem-Solving Skills
Be prepared to discuss how you've identified regulatory risks in the past and the solutions you recommended. Companies love candidates who can think critically and proactively address potential issues before they arise.
✨Communicate Clearly and Organise Your Thoughts
Strong communication skills are a must for this role. Practice articulating your thoughts clearly and concisely. You might want to rehearse common interview questions with a friend to ensure you can convey your ideas effectively during the actual interview.
