At a Glance
- Tasks: Support regulatory activities for medical devices and ensure compliance across global markets.
- Company: Growing medical device manufacturer with a diverse product portfolio.
- Benefits: Competitive salary, hands-on experience, and opportunities for career growth.
- Other info: Collaborative environment with exposure to the full product lifecycle.
- Why this job: Join a dynamic team and make a real impact in healthcare innovation.
- Qualifications: Experience in Regulatory Affairs within the medical device sector is essential.
The predicted salary is between 40000 - 50000 £ per year.
Cure Talent are delighted to be partnered with a growing medical device manufacturer with a broad and diverse product portfolio across areas including IV therapy, diabetes care, surgical, anaesthesia and consumer health. Following continued expansion, they are now looking to add another Regulatory Affairs Specialist to their Quality & Regulatory team.
As the new Regulatory Affairs Specialist, you will support the ongoing development, maintenance and execution of regulatory activities across the business. This is a hands‑on role with exposure across the full product lifecycle, working closely with internal teams to ensure products remain compliant across multiple global markets while helping to define regulatory strategy.
To be successful as the new Regulatory Affairs Specialist, you will have proven experience operating within Regulatory Affairs in the medical device sector, with detailed exposure to technical documentation, global regulatory frameworks including MDR and FDA, and supporting regulatory strategy across a range of products.
Key Responsibilities- Support and maintain the Quality Management System in line with ISO 13485 requirements
- Prepare, review and maintain technical documentation across MDD, MDR, IVDR, UKCA, FDA and procedure packs
- Ensure ongoing compliance with applicable regulatory requirements and standards
- Support document control activities including procedures, labelling and product documentation
- Contribute to UDI implementation and product lifecycle activities
- Coordinate and support internal and external audits
- Monitor regulatory changes and support implementation across the business
- Proven Regulatory Affairs experience within the medical device industry
- Experience supporting regulatory strategy and submissions activities
- Working knowledge of MDR and FDA regulatory frameworks
- Strong understanding of ISO 13485
- Experience working with technical documentation and regulatory files
- Strong organisational skills with attention to detail
- Ability to work cross‑functionally within a regulated environment
If you have the necessary skills and experience, please get in touch with Kris Holmes today or click apply now.
Medical Device Regulatory Affairs Specialist. Job in London LilyLifestyle Jobs employer: Cure Talent Ltd
As a leading medical device manufacturer based in London, we pride ourselves on fostering a collaborative and innovative work environment that empowers our employees to thrive. Our commitment to professional development is evident through tailored training programmes and opportunities for career advancement, ensuring that you can grow alongside our diverse product portfolio. Join us and be part of a team that values compliance, quality, and the positive impact we make in healthcare.
StudySmarter Expert Advice🤫
We think this is how you could land Medical Device Regulatory Affairs Specialist. Job in London LilyLifestyle Jobs
✨Tip Number 1
Network like a pro! Reach out to professionals in the medical device sector on LinkedIn or at industry events. We all know that sometimes it’s not just what you know, but who you know that can help you land that Regulatory Affairs Specialist role.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of MDR and FDA regulations. We recommend creating a cheat sheet of key points to discuss. This will show your potential employer that you’re not just familiar with the requirements, but you’re ready to tackle them head-on!
✨Tip Number 3
Don’t underestimate the power of follow-ups! After an interview, send a quick thank-you email to express your appreciation. It keeps you fresh in their minds and shows your enthusiasm for the role. We believe this small gesture can make a big difference.
✨Tip Number 4
Apply through our website! We’ve got a streamlined process that makes it easy for you to showcase your skills. Plus, it gives us a chance to see your application in the best light possible. Let’s get you that job!
We think you need these skills to ace Medical Device Regulatory Affairs Specialist. Job in London LilyLifestyle Jobs
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the role of a Regulatory Affairs Specialist. Highlight your experience in the medical device sector, especially with regulatory frameworks like MDR and FDA. We want to see how your skills align 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 affairs and how your background makes you a perfect fit for our team. Don’t forget to mention specific experiences that relate to the job description.
Showcase Your Attention to Detail:In regulatory affairs, attention to detail is key. When writing your application, make sure there are no typos or errors. We appreciate candidates who take the time to ensure their documents are polished and professional.
Apply Through Our Website:We encourage you to apply directly 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 StudySmarter!
How to prepare for a job interview at Cure Talent Ltd
✨Know Your Regulations
Make sure you brush up on the key regulations like MDR and FDA before your interview. Being able to discuss these frameworks confidently will show that you’re not just familiar with them, but that you can apply this knowledge practically in your role.
✨Technical Documentation Mastery
Prepare to talk about your experience with technical documentation. Bring examples of documents you've worked on, and be ready to explain how you ensured compliance with ISO 13485. This will demonstrate your hands-on experience and attention to detail.
✨Show Your Organisational Skills
Since this role requires strong organisational skills, think of specific instances where you successfully managed multiple projects or tasks. Be ready to share how you prioritised your workload and maintained compliance across various regulatory requirements.
✨Cross-Functional Collaboration
Highlight your ability to work cross-functionally. Prepare examples of how you’ve collaborated with different teams in the past, especially in a regulated environment. This will illustrate your teamwork skills and your understanding of how regulatory affairs fit into the bigger picture.
