At a Glance
- Tasks: Support regulatory activities and ensure compliance for innovative medical devices.
- Company: Growing medical device manufacturer with a diverse product portfolio.
- Benefits: Competitive salary, career development opportunities, and a collaborative work environment.
- Other info: Hands-on role with exposure to the full product lifecycle and global markets.
- Why this job: Join a dynamic team and make a real impact in healthcare innovation.
- Qualifications: Experience in Regulatory Affairs within the medical device sector is essential.
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 employer: CURE TALENT LIMITED
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 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 people in the medical device industry, especially those in regulatory affairs. Attend industry events or webinars to make connections and learn about potential job openings.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of MDR and FDA regulations. Be ready to discuss how your experience aligns with the company's needs and how you can contribute to their regulatory strategy.
✨Tip Number 3
Showcase your organisational skills! During interviews, share examples of how you've managed technical documentation and compliance tasks. This will demonstrate your attention to detail and ability to work cross-functionally.
✨Tip Number 4
Don't forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive about their job search.
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 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 perfect fit for our team. Don’t forget to mention any relevant projects or achievements that showcase your expertise.
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 us you’re keen on joining our team at StudySmarter!
How to prepare for a job interview at CURE TALENT LIMITED
✨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.
✨Cross-Functional Collaboration
Highlight your ability to work with different teams. Discuss any experiences where you coordinated with internal or external stakeholders to achieve regulatory goals. This will show that you can thrive in a collaborative environment, which is crucial for this role.
