At a Glance
- Tasks: Lead regulatory strategy and document review for life-saving medical devices.
- Company: Global medical device company known for innovative technologies.
- Benefits: Competitive salary, mentorship opportunities, and a chance to impact healthcare.
- Other info: Collaborative team environment with opportunities for professional growth.
- Why this job: Join a hands-on role that shapes the future of medical technology.
- Qualifications: Experience in Regulatory Affairs with EU MDR and US FDA knowledge.
The predicted salary is between 55000 - 70000 £ 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 in Crewe employer: Cure Talent
Join a dynamic and innovative medical device manufacturer in Slough, where your role as Procurement Manager will not only enhance your career but also contribute to meaningful healthcare solutions. With a strong focus on employee development, a collaborative work culture, and the opportunity to manage significant procurement budgets, this position offers a unique chance to make a real impact while enjoying a supportive environment that values growth and excellence.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Regulatory Affairs Specialist in Crewe
✨Tip Number 1
Network like a pro! Reach out to your connections in the medical device sector and let them know you're on the hunt for a Senior Regulatory Affairs Specialist role. You never know who might have the inside scoop on openings or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of EU MDR and US FDA frameworks. Be ready to discuss your hands-on experience with regulatory submissions and document reviews, as these are key areas they'll want to hear about.
✨Tip Number 3
Showcase your mentorship skills! If you’ve guided peers in previous roles, be sure to highlight this during interviews. Companies love candidates who can contribute to team development and continuous improvement.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, we’re always looking for passionate individuals like you to join our team!
We think you need these skills to ace Senior Regulatory Affairs Specialist in Crewe
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, as well as any hands-on regulatory activities you've been involved in. We want to see how your background aligns with our needs!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're passionate about regulatory affairs in the medical device sector. Share specific examples of your achievements and how they relate to the responsibilities outlined in the job description. We love a good story!
Showcase Your Team Spirit:Since this role involves working closely with cross-functional teams, make sure to highlight your collaborative skills. Mention any experiences where you’ve provided mentorship or guidance to peers, as we value teamwork and continuous improvement at StudySmarter.
Apply Through Our Website:Don’t forget to apply through our website! It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it gives you a chance to explore more about our company culture and values while you’re at it!
How to prepare for a job interview at Cure Talent
✨Know Your Regulations Inside Out
Make sure you brush up on the EU MDR and US FDA frameworks before your interview. Be ready to discuss specific examples of how you've navigated these regulations in your previous roles, especially regarding Technical Documentation and 510(k) submissions.
✨Showcase Your Hands-On Experience
Prepare to talk about your direct involvement in regulatory activities. Highlight any international registrations you've supported and be specific about your role in document reviews and submissions. This will demonstrate your practical knowledge and readiness for the hands-on nature of the position.
✨Be Ready to Discuss Strategy
Think about how you've contributed to defining regulatory strategies in past roles. Be prepared to share your insights on aligning regulatory objectives with business goals, as this is crucial for the Senior RA Specialist role.
✨Mentorship Matters
Since you'll be providing guidance to peers, come prepared with examples of how you've mentored others in the past. Discuss your approach to supporting team development and how you can contribute to continuous improvement in regulatory processes.
