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- Tasks: Ensure compliance with EU and US regulations for AI medical technology.
- Company: Leading AI medical tech firm based in Oxford.
- Benefits: Competitive salary, health benefits, and opportunities to shape heart health.
- Why this job: Make a meaningful impact in cardiovascular diagnostics and innovate in healthcare.
- Qualifications: 3-5 years experience in SaMD medical device industry and regulatory knowledge.
- Other info: Join a dynamic team dedicated to advancing heart health technology.
The predicted salary is between 36000 - 60000 £ per year.
A leading AI medical technology firm based in Oxford is seeking a Regulatory Affairs Specialist to ensure compliance with EU and US regulations. This role involves preparing CE mark documentation, supporting FDA submissions, and managing post-market regulatory activities.
Candidates should have 3-5 years of experience in the SaMD medical device industry and a strong understanding of regulatory requirements.
Join us to shape the future of heart health and make a meaningful impact in cardiovascular diagnostics.
Regulatory Affairs Specialist - SaMD AI for Heart Health in Oxford employer: Ultromics
Contact Detail:
Ultromics Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Specialist - SaMD AI for Heart Health in Oxford
✨Tip Number 1
Network like a pro! Reach out to professionals in the regulatory affairs space, especially those in the SaMD medical device industry. LinkedIn is a great place to start – connect, engage, and don’t be shy about asking for advice or insights.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of EU and US regulations. We recommend creating a cheat sheet of key points related to CE mark documentation and FDA submissions. This will help you feel confident and ready to impress during your interview.
✨Tip Number 3
Showcase your experience! When discussing your background, highlight specific projects where you ensured compliance or managed post-market activities. Use real examples to demonstrate your expertise and how you can contribute to shaping the future of heart health.
✨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 and engaged with our company. Let’s make a meaningful impact together!
We think you need these skills to ace Regulatory Affairs Specialist - SaMD AI for Heart Health in Oxford
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your experience in the SaMD medical device industry. We want to see how your background aligns with the regulatory requirements mentioned in the job description.
Showcase Relevant Experience: When writing your cover letter, focus on your 3-5 years of experience in regulatory affairs. We’re keen to know about your work with CE mark documentation and FDA submissions, so don’t hold back!
Be Clear and Concise: Keep your application straightforward and to the point. We appreciate clarity, especially when it comes to complex topics like compliance and regulations. Make it easy for us to see your qualifications!
Apply Through Our Website: We encourage you to submit your application through our website. It’s the best way for us to receive your details and ensures you’re considered for this exciting opportunity in shaping heart health!
How to prepare for a job interview at Ultromics
✨Know Your Regulations
Make sure you brush up on the latest EU and US regulations related to SaMD. Familiarise yourself with CE mark documentation and FDA submission processes, as these will likely come up in your interview. Being able to discuss specific regulations confidently will show that you're serious about the role.
✨Showcase Your Experience
Prepare to talk about your previous roles in the SaMD medical device industry. Highlight specific projects where you ensured compliance or managed regulatory activities. Use concrete examples to demonstrate how your experience aligns with the job requirements.
✨Understand the Company’s Mission
Research the company’s focus on heart health and cardiovascular diagnostics. Be ready to discuss how your skills can contribute to their mission. Showing genuine interest in their work will help you stand out as a candidate who is not just looking for any job, but is passionate about making an impact.
✨Prepare Questions
Think of insightful questions to ask during the interview. This could be about their current projects, challenges they face in regulatory affairs, or how they envision the future of AI in heart health. Asking thoughtful questions shows your enthusiasm and helps you gauge if the company is the right fit for you.
