At a Glance
- Tasks: Support regulatory activities and ensure compliance for medical devices across global markets.
- Company: Join a growing medical device manufacturer with a diverse product portfolio.
- Benefits: Competitive salary, career growth, and hands-on experience in a dynamic environment.
- Other info: Collaborative team culture with opportunities for professional development.
- Why this job: Make a real impact in healthcare by ensuring product compliance and safety.
- Qualifications: Experience in Regulatory Affairs within the medical device sector is essential.
The predicted salary is between 45000 - 55000 £ 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.
Regulatory Affairs Specialist. Job in London LilyLifestyle Jobs employer: Cure Talent Ltd
Join a dynamic and innovative medical device manufacturer in London, where your expertise as a Regulatory Affairs Specialist will be valued and nurtured. With a strong commitment to employee development, a collaborative work culture, and a diverse product portfolio, this company offers a unique opportunity to contribute to meaningful healthcare solutions while ensuring compliance across global markets. Enjoy the benefits of working in a supportive environment that prioritises professional growth and embraces regulatory challenges.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Affairs Specialist. Job in London LilyLifestyle Jobs
✨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 MDR and FDA regulations. We recommend creating a cheat sheet of key points to discuss, so you can impress your interviewers with your expertise.
✨Tip Number 3
Showcase your hands-on experience! Be ready to share specific examples of how you've supported regulatory strategy and maintained compliance in previous roles. We love hearing about real-world applications of your skills.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we’re always looking for passionate candidates who are eager to contribute to our growing team.
We think you need these skills to ace Regulatory Affairs Specialist. Job in London LilyLifestyle Jobs
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 regulatory frameworks like MDR and FDA. We want to see how your skills match 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 great fit for our team. Don’t forget to mention your experience with technical documentation and compliance.
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 through our website for the best chance of getting noticed. It’s super easy, and you’ll be able to submit all your documents in one go. Plus, it helps us keep track of your application!
How to prepare for a job interview at Cure Talent Ltd
✨Know Your Regulations
Make sure you brush up on the key regulatory frameworks like MDR and FDA before your interview. Being able to discuss these in detail will show that you’re not just familiar with them, but that you can apply this knowledge practically.
✨Showcase Your Experience
Prepare specific examples from your past roles where you’ve successfully navigated regulatory challenges or contributed to compliance efforts. This will help demonstrate your hands-on experience and how it aligns with the role.
✨Understand the Company’s Products
Take some time to research the company’s product portfolio. Knowing their products and how they fit into the regulatory landscape will allow you to speak more confidently about how you can contribute to their success.
✨Ask Insightful Questions
Prepare thoughtful questions about the company’s regulatory strategy and how they handle compliance across different markets. This shows your genuine interest in the role and helps you assess if the company is the right fit for you.
