At a Glance
- Tasks: Lead regulatory strategy and support product portfolios in a hands-on role.
- Company: Global medical device company known for life-saving technologies.
- Benefits: Competitive salary, career growth, and mentorship opportunities.
- Other info: Join a dynamic team focused on continuous improvement and international registrations.
- Why this job: Make a real impact in the medical device sector with innovative products.
- Qualifications: Experience in Regulatory Affairs, EU MDR, and US FDA frameworks required.
The predicted salary is between 60000 - 80000 £ per year.
Cure Talent are delighted to be partnered with a global medical device company recognised for its life-saving technologies. As they continue to expand their portfolio, we have an opportunity for a Regulatory Affairs Lead to join their team in a hands-on role supporting product portfolios.
As the new Regulatory Affairs Lead, you will operate as a senior individual contributor within a team of three, supporting regulatory activities while remaining heavily involved in execution. The role spans the full product lifecycle, with a strong focus on document review, international registrations, and helping to define regulatory strategy for new and existing products across all classes of device, including Class III. You will work closely with senior stakeholders, provide mentorship to peers, and contribute to continuous improvement across regulatory processes.
To be successful as the new Regulatory Affairs Lead, you will have proven experience operating in Regulatory Affairs within the medical device sector with detailed experience in EU MDR and US FDA frameworks, including Technical Documentation and 510(k) submissions. You will have hands-on experience supporting international registrations, strong exposure to document review activities, and a solid understanding of clinical evaluation and post-market requirements.
Key Responsibilities
- Helping to define regulatory strategy across assigned product portfolios, ensuring alignment with business and market access objectives.
- Lead and perform detailed review of regulatory documentation, including Technical Documentation, Clinical Evaluation Reports and submission dossiers.
- Prepare, review and support global submissions including EU MDR and US FDA 510(k), as well as wider international registrations.
- Act as a key regulatory contact within cross-functional teams, providing guidance on classification, clinical pathways and conformity assessment routes.
- Support regulatory interactions, including responses to authority queries, audits and inspections.
- Monitor regulatory developments and assess impact to ongoing and future activities.
- Provide mentorship and guidance within the team, supporting development without direct line management responsibility.
Experience and Skills Required
- Proven experience within Regulatory Affairs in the medical device sector.
- Strong working knowledge of EU MDR and US FDA frameworks, including Technical Documentation and 510(k) submissions.
- Experience helping to define regulatory strategy alongside hands-on submission and documentation activity.
- Exposure to international registrations across multiple markets is advantageous.
- Experience with clinical evaluation and post-market clinical follow-up activities is desirable.
If you have the necessary skills and experience, please get in touch with Kris Holmes today or click apply now.
Locations
Regulatory Affairs Lead in Cheshire, Crewe employer: Cure Talent
Join a global leader in medical devices, where your expertise as a Regulatory Affairs Lead will be valued in a collaborative and innovative environment. With a strong focus on employee development, you will have the opportunity to mentor peers while contributing to life-saving technologies that make a real difference. Located in a vibrant area, the company offers a supportive work culture and a commitment to continuous improvement, making it an excellent place for professionals seeking meaningful and rewarding careers.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Affairs Lead in Cheshire, Crewe
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We think you need these skills to ace Regulatory Affairs Lead in Cheshire, Crewe
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at Cure Talent!
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Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At Cure Talent, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at Cure Talent
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Cure Talent that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
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If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
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