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- Tasks: Support regulatory activities and ensure compliance for medical devices across global markets.
- Company: Growing medical device manufacturer with a diverse product portfolio.
- Benefits: Hands-on role with exposure to the full product lifecycle and career development opportunities.
- Other info: Collaborative environment with strong focus on quality and compliance.
- Why this job: Make a real impact in healthcare by ensuring products meet global regulatory standards.
- 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
If you have the necessary skills and experience, please get in touch with Kris Holmes today or click apply now.
Regulatory Affairs Specialist in Cowley employer: CURE TALENT LIMITED
Contact Detail:
CURE TALENT LIMITED Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Specialist in Cowley
✨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 personal connections can be in 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 it 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 Cowley
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 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 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, we love seeing applications come directly from our site!
How to prepare for a job interview at CURE TALENT LIMITED
✨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
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 discuss how you've ensured compliance with ISO 13485. This will demonstrate your hands-on experience and attention to detail.
✨Show Your Organisational Skills
Highlight your organisational skills during the interview. You might want to share specific examples of how you’ve managed multiple projects or maintained compliance across various regulatory requirements. This will help illustrate your ability to work cross-functionally in a regulated environment.
✨Ask Insightful Questions
Prepare some thoughtful questions about the company’s regulatory strategy or how they handle audits. This shows your genuine interest in the role and helps you understand how you can contribute to their ongoing success in the medical device sector.