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- Tasks: Define regulatory strategies and support product portfolios in a hands-on role.
- Company: Global medical device company known for life-saving technologies.
- Benefits: Competitive salary, mentorship opportunities, and a chance to impact healthcare.
- Other info: Dynamic role with opportunities for professional growth and development.
- Why this job: Join a team making a difference in medical technology and patient care.
- Qualifications: Experience in Regulatory Affairs with knowledge of EU MDR and US FDA frameworks.
The predicted salary is between 50000 - 65000 £ 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 Senior Regulatory Affairs Specialist to join their team in a hands-on role supporting product portfolios.
As the new Senior RA Specialist, 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 Senior RA Specialist, 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.
- 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.
Senior Regulatory Affairs Specialist employer: Cure Talent
Contact Detail:
Cure Talent Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Regulatory Affairs Specialist
✨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 Senior Regulatory Affairs Specialist role.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of EU MDR and US FDA frameworks. We recommend creating a cheat sheet of key points to discuss, especially around document review and international registrations, so you can impress those senior stakeholders.
✨Tip Number 3
Showcase your hands-on experience! During interviews, share specific examples of your work with Technical Documentation and 510(k) submissions. We want to hear about your successes and how you’ve contributed to regulatory strategy.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we’re always looking for passionate individuals who can help us drive continuous improvement in regulatory processes.
We think you need these skills to ace Senior Regulatory Affairs Specialist
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Senior Regulatory Affairs Specialist role. Highlight your experience with EU MDR and US FDA frameworks, and don’t forget to showcase your hands-on experience with international registrations and document reviews.
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you’re the perfect fit for this role. Mention specific projects or experiences that align with the responsibilities listed in the job description, especially around regulatory strategy and mentorship.
Showcase Your Achievements: When detailing your experience, focus on achievements rather than just duties. Use metrics where possible to demonstrate your impact in previous roles, especially in areas like successful submissions or improvements in regulatory processes.
Apply Through Our Website: We encourage you to apply through our website for a smoother application process. It’s the best way for us to receive your application and ensures you don’t miss out on any important updates from our team!
How to prepare for a job interview at Cure Talent
✨Know Your Regulations
Make sure you brush up on the EU MDR and US FDA frameworks before your interview. Being able to discuss specific regulations and how they apply to the role will show that you're not just familiar with the basics, but that you truly understand the intricacies of regulatory affairs in the medical device sector.
✨Showcase Your Experience
Prepare to share detailed examples from your past roles where you've successfully navigated regulatory submissions or document reviews. Highlight any international registrations you've been involved with, as this will demonstrate your hands-on experience and ability to contribute to the team right away.
✨Engage with Stakeholders
Since the role involves working closely with senior stakeholders, think about how you can illustrate your communication skills. Be ready to discuss how you've previously collaborated with cross-functional teams and provided guidance on regulatory strategies, as this will be key to your success in the position.
✨Stay Updated on Trends
Regulatory affairs is a constantly evolving field, so make sure you're aware of the latest developments and trends. Bring up any recent changes in regulations or industry news during your interview to show that you're proactive and committed to continuous improvement in your work.