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, 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 Leeds 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 ample career development opportunities and foster a collaborative culture that values diversity and inclusion. Join us to be part of a team that not only prioritises regulatory excellence but also supports your professional journey in a meaningful way.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Regulatory Affairs Associate - Medical Devices in Leeds
✨Tip Number 1
Network like a pro! Reach out to professionals in the Regulatory Affairs field, especially those who work with medical devices. Attend industry events or webinars to make connections and learn about potential job openings.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of MDD, MDR, and UKCA requirements. We want you to be able to discuss how your experience aligns with the role and demonstrate your understanding of regulatory compliance.
✨Tip Number 3
Showcase your skills! Create a portfolio that highlights your experience with Technical Documentation and regulatory submissions. This will give you an edge and show potential employers what you can bring to the table.
✨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 Leeds
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 a lot of documentation and compliance checks, we need to know you can communicate effectively and manage multiple tasks.
Be Specific About Experience:When detailing your experience, be specific about your work with Technical Documentation, regulatory gap analyses, and post-market surveillance. We love seeing concrete examples that demonstrate your expertise in the field!
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. We can’t wait to see what you bring to the table!
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 also understand the nuances of regulatory affairs in the medical device sector.
✨Showcase Your Documentation Skills
Prepare examples of your experience with Technical Documentation and Technical Files. Be ready to discuss how you've maintained compliance and conducted gap analyses in previous roles. This will demonstrate your hands-on experience and attention to detail.
✨Be Ready for Scenario Questions
Expect questions about how you would handle specific regulatory challenges, such as reviewing design changes or managing CAPA. Think through some scenarios beforehand so you can articulate your thought process and problem-solving skills clearly.
✨Communicate Clearly and Organised
Strong communication is key in this role. Practice explaining complex regulatory concepts in simple terms. During the interview, keep your answers structured and concise, which will reflect your organisational skills and ability to manage multiple tasks effectively.
