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- Tasks: Support regulatory submissions and maintain Technical Files for medical devices.
- Company: Join a leading British Medical Device Manufacturer with a strong reputation.
- Benefits: Enjoy opportunities for growth, collaboration, and a dynamic work environment.
- Why this job: Be part of a team that ensures compliance and quality in healthcare innovation.
- Qualifications: Experience in Regulatory Affairs and knowledge of ISO 13485 and medical device regulations required.
- Other info: Ideal for those passionate about making a difference in the medical field.
The predicted salary is between 36000 - 60000 £ per year.
Cure Talent are delighted to be partnered with a well-established, British Medical Device Manufacturer who, due to continued growth and investment, have an exciting opportunity for a Regulatory & Quality Assistant to join their team. This role is predominantly Regulatory Affairs focused, supporting the creation and maintenance of Technical Files and regulatory submissions in line with ISO 13485, MDR and UK MDR requirements. The position will also involve elements of Quality Assurance, including internal auditing and supporting the ongoing compliance of the Quality Management System.
The ideal candidate will have a proven background within Medical Device Regulatory Affairs and possess a strong understanding of ISO 13485 and medical device regulations. You will have experience in the creation and/or updating of Technical Files under MDR, assisting with regulatory submissions and internal auditing.
Key Responsibilities:- Assist with the preparation of regulatory submissions and Technical Files to EU MDR 2017/745 and UK MDR 2002
- Conduct internal audits and follow up on corrective actions
- Maintain documentation including procedures, protocols, validation reports, audit records, and CAPAs
- Support the maintenance of the company’s QMS in accordance with ISO 13485:2016
- Monitor changes in regulations and support implementation of updates to internal processes
- Collaborate with cross-functional teams including Engineering, Design, Sales, and Customer Service to ensure compliance is embedded throughout the organisation
- Provide support during notified body, supplier and customer audits
The ideal candidate will have:
- Proven experience in a Regulatory Affairs focused role within medical devices
- Experience in the compilation and updating of Technical Files under MDR
- Proven knowledge and experience of ISO 13485, EU MDR, and UK MDR
- Experience with Class 2a devices as a minimum
- ISO 13485 Internal or Lead auditor qualification is highly advantageous
Regulatory Affairs Associate employer: Cure Talent
Contact Detail:
Cure Talent Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Associate
✨Tip Number 1
Familiarise yourself with the latest updates on ISO 13485 and the EU MDR regulations. Being well-versed in these standards will not only boost your confidence during interviews but also demonstrate your commitment to staying current in the field.
✨Tip Number 2
Network with professionals in the Regulatory Affairs sector, especially those who work with medical devices. Attend industry conferences or webinars to connect with potential colleagues and learn about best practices that can set you apart from other candidates.
✨Tip Number 3
Prepare to discuss specific examples of your experience with Technical Files and regulatory submissions. Having concrete instances ready will help you illustrate your expertise and problem-solving skills during the interview process.
✨Tip Number 4
Showcase your ability to collaborate with cross-functional teams. Highlight any past experiences where you worked alongside engineering, design, or sales teams to ensure compliance, as this is a key aspect of the role you're applying for.
We think you need these skills to ace Regulatory Affairs Associate
Some tips for your application 🫡
Understand the Role: Before applying, make sure to thoroughly understand the responsibilities and requirements of the Regulatory Affairs Associate position. Familiarise yourself with ISO 13485, MDR, and UK MDR regulations as these are crucial for the role.
Tailor Your CV: Customise your CV to highlight your relevant experience in Regulatory Affairs, particularly within medical devices. Emphasise your knowledge of Technical Files, regulatory submissions, and any internal auditing experience you possess.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for regulatory affairs and your understanding of the medical device industry. Mention specific experiences that align with the job description, such as your work with ISO 13485 or your involvement in regulatory submissions.
Proofread Your Application: Before submitting your application, carefully proofread all documents for spelling and grammatical errors. A polished application reflects your attention to detail, which is essential in regulatory affairs.
How to prepare for a job interview at Cure Talent
✨Know Your Regulations
Make sure you have a solid understanding of ISO 13485, EU MDR, and UK MDR. Brush up on the latest updates and be prepared to discuss how these regulations impact the role you're applying for.
✨Showcase Your Experience
Be ready to share specific examples from your past roles where you've created or updated Technical Files and handled regulatory submissions. Highlight any internal auditing experience as well.
✨Demonstrate Cross-Functional Collaboration
Since this role involves working with various teams, think of instances where you've successfully collaborated with Engineering, Design, or Sales. Be prepared to explain how you ensured compliance across departments.
✨Ask Insightful Questions
Prepare thoughtful questions about the company's Quality Management System and how they handle regulatory changes. This shows your genuine interest in the role and helps you assess if it's the right fit for you.
