At a Glance
- Tasks: Support regulatory activities and ensure compliance with global standards in a dynamic medical device company.
- Company: Rapidly growing medical device company with a diverse portfolio.
- Benefits: Hybrid work model, competitive salary, and opportunities for professional growth.
- Other info: Exciting opportunity for career advancement in a supportive environment.
- Why this job: Join a dedicated team and make a real impact in the medical device industry.
- Qualifications: Experience in Regulatory Affairs within the medical device sector and strong attention to detail.
The predicted salary is between 36000 - 60000 £ 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.
This is a hybrid role with the expectation of being on site once or twice a week in Uxbridge.
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
Experience and Skills Required
- 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
- Multi‑language skills would be an advantage.
Regulatory Affairs Specialist in Uxbridge employer: Cure Talent
Join a rapidly growing medical device company in Uxbridge, where you will be part of a dedicated Quality & Regulatory team that values innovation and compliance. With a strong focus on employee development, this hybrid role offers the chance to work collaboratively across diverse projects while enjoying a supportive work culture that encourages professional growth and continuous learning. Benefit from a competitive salary, flexible working arrangements, and the opportunity to make a meaningful impact in the healthcare sector.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Affairs Specialist in Uxbridge
✨Tip Number 1
Network like a pro! Reach out to professionals in the medical device industry 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 ISO standards and regulatory compliance. We recommend practising common interview questions related to Quality Management Systems and showcasing your problem-solving skills.
✨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 expertise in regulatory affairs within the medical device sector.
✨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 Uxbridge
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 industry and any relevant regulatory knowledge, especially around ISO standards and compliance.
Craft a Compelling Cover Letter:Your cover letter should tell us why you're the perfect fit for this role. Share specific examples of your past work in regulatory affairs and how it aligns with our needs at StudySmarter.
Showcase Your Attention to Detail:In regulatory affairs, attention to detail is key. Use your application to demonstrate this skill—proofread your documents carefully and ensure everything is clear and concise.
Apply Through Our Website:We encourage you to apply through our website for a smoother process. It helps us keep track of your application and ensures you don’t miss out on any important updates from us!
How to prepare for a job interview at Cure Talent
✨Know Your Regulations
Make sure you brush up on the latest regulations like UKCA, EU MDR, and FDA standards. Being able to discuss these confidently will show that you're not just familiar with the requirements but also proactive about staying updated.
✨Showcase Your Documentation Skills
Prepare examples of technical files or regulatory documentation you've worked on in the past. Highlight your experience with QMS and how you've contributed to maintaining compliance. This will demonstrate your hands-on experience and attention to detail.
✨Be Ready for Problem-Solving Questions
Expect questions that assess your logical and proactive problem-solving skills. Think of specific scenarios where you successfully navigated regulatory challenges and be ready to share those stories during the interview.
✨Highlight Your Interpersonal Skills
Since this role involves working closely with various teams and stakeholders, be prepared to discuss how you've effectively collaborated in the past. Share examples that showcase your strong communication and organisational skills.
