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: Hybrid work model, competitive salary, and opportunities for professional growth.
- Other info: Hands-on role with exposure to the full product lifecycle and excellent career advancement potential.
- 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 regulations.
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. 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
- 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.
If you have the necessary skills and experience, please get in touch with Kris Holmes today or click apply now.
Regulatory Affairs Specialist in Uxbridge employer: MindMatch
Join a dynamic and innovative medical device manufacturer in Uxbridge, 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 the opportunity to engage with a diverse product portfolio, this role offers a meaningful career path in a rapidly expanding industry. Enjoy the flexibility of a hybrid working model while contributing to impactful regulatory strategies that ensure compliance across global markets.
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 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 wait for job postings! Reach out directly to companies you admire, like the one we’re partnered with. A proactive approach can set you apart from other candidates and show your genuine interest in their work.
✨Tip Number 4
Finally, apply through our website! It’s the best way to ensure your application gets noticed. Plus, we’re here to support you every step of the way in your journey to becoming a Regulatory Affairs Specialist.
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 sector and any specific knowledge of MDR and FDA regulations. We want to see how your skills align with 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 filling out your application, double-check for any typos or errors. We appreciate candidates who take the time to ensure their submissions are polished and professional.
Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it shows you’re keen on joining our team at StudySmarter!
How to prepare for a job interview at MindMatch
✨Know Your Regulations
Make sure you brush up on the latest 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.
✨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. 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.
✨Stay Updated on Industry Changes
Research recent changes in regulatory requirements and be ready to discuss how they might impact the company. Showing that you’re proactive about staying informed will highlight your commitment to the role and the industry.
