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- Tasks: Support regulatory activities and ensure compliance for innovative medical devices.
- Company: Growing medical device manufacturer with a diverse product portfolio.
- Benefits: Competitive salary, career development opportunities, and a collaborative work environment.
- Other info: Hands-on role with exposure to the full product lifecycle and excellent growth potential.
- Why this job: Make a real impact in healthcare by ensuring product compliance across global markets.
- Qualifications: Experience in Regulatory Affairs within the medical device sector and knowledge of MDR and FDA.
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
Regulatory Affairs Specialist in London employer: Cure Talent Ltd
Contact Detail:
Cure Talent Ltd Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Specialist in London
✨Tip Number 1
Network like a pro! Reach out to professionals in the medical device sector on LinkedIn or at industry events. We can’t stress enough how valuable connections can be when it comes to landing 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, so you can confidently showcase your expertise during the interview.
✨Tip Number 3
Don’t just apply anywhere; focus on companies that align with your values and interests. We suggest checking out our website for tailored job listings that match your skills in regulatory affairs within the medical device industry.
✨Tip Number 4
Follow up after interviews! A quick thank-you email can set you apart from other candidates. We believe this shows your enthusiasm for the role and keeps you fresh in the interviewer’s mind.
We think you need these skills to ace Regulatory Affairs Specialist in London
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Regulatory Affairs Specialist role. Highlight your experience in the medical device sector and any specific knowledge of MDR and FDA regulations. We want to see how your skills align with what we're looking for!
Showcase Your Experience: In your cover letter, don’t just list your previous roles; tell us about your hands-on experience with technical documentation and compliance. Share specific examples that demonstrate your understanding of ISO 13485 and regulatory frameworks.
Be Clear and Concise: When writing your application, keep it clear and concise. Use bullet points where possible to make it easy for us to read. We appreciate a well-structured application that gets straight to the point!
Apply Through Our Website: We encourage you to apply through our website for the best chance of getting noticed. It’s super easy, and you’ll be able to submit all the necessary documents in one go. Let’s get your application in!
How to prepare for a job interview at Cure Talent Ltd
✨Know Your Regulations
Make sure you brush up on the latest regulations like MDR and FDA. 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 and other standards. This will demonstrate your hands-on experience in the field.
✨Showcase Your Organisational Skills
Regulatory Affairs requires a keen eye for detail and strong organisational skills. Be prepared to share specific examples of how you’ve managed multiple projects or documents simultaneously, and how you kept everything compliant and on track.
✨Cross-Functional Collaboration
Highlight your ability to work with different teams. Discuss any experiences where you coordinated with internal or external stakeholders to achieve regulatory goals. This will show that you can navigate the complexities of a regulated environment effectively.