At a Glance
- Tasks: Support regulatory activities and ensure compliance for medical devices across global markets.
- Company: Growing medical device manufacturer with a diverse product portfolio.
- Benefits: Competitive salary, hands-on experience, and opportunities for professional growth.
- Other info: Collaborative environment with a focus on quality and compliance.
- Why this job: Join a dynamic team and make a real impact in the healthcare industry.
- Qualifications: Experience in Regulatory Affairs within the medical device sector and knowledge of global frameworks.
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.
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 employer: Broughton Group
Join a dynamic and innovative medical device manufacturer that prioritises employee development and fosters a collaborative work culture. As a Regulatory Affairs Specialist, you will benefit from hands-on experience across the full product lifecycle while working in a supportive environment that values compliance and quality. With opportunities for professional growth and a commitment to maintaining high standards, this company is an excellent employer for those seeking meaningful and rewarding careers in the healthcare sector.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Affairs Specialist
✨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, so you can confidently showcase your expertise during those crucial conversations.
✨Tip Number 3
Don’t forget to follow up after interviews! A quick thank-you email can go a long way in keeping you top of mind. We suggest mentioning something specific from your conversation to show your genuine interest in the role.
✨Tip Number 4
Apply directly through our website! It’s the best way to ensure your application gets seen by the right people. Plus, we often have exclusive roles listed there that you won’t find anywhere else.
We think you need these skills to ace Regulatory Affairs Specialist
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 regulatory frameworks you've worked with, 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 perfect fit for our team. Don’t forget to mention any hands-on experience you have 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 upload all your documents in one go. Plus, it helps us keep track of your application better!
How to prepare for a job interview at Broughton Group
✨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.
✨Technical Documentation Mastery
Since the role involves a lot of technical documentation, be prepared to talk about your experience with it. Bring examples of documents you've worked on or explain how you've ensured compliance with ISO 13485 in past roles.
✨Show Your Organisational Skills
Highlight your organisational skills during the interview. You might want to share specific instances where your attention to detail made a difference, especially in a regulated environment. This will demonstrate your ability to manage multiple tasks effectively.
✨Cross-Functional Collaboration
This role requires working closely with various teams, so be ready to discuss how you've successfully collaborated in the past. Share examples of how you’ve coordinated with different departments to ensure compliance and support regulatory strategy.
