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- Tasks: Lead regulatory submissions for innovative medical devices in the US and EU.
- Company: Dynamic medical device company focused on compliance and innovation.
- Benefits: Short-term consultancy with high impact and collaborative team environment.
- Why this job: Make a real difference in critical regulatory submissions and gain valuable experience.
- Qualifications: Senior-level regulatory experience with FDA and EU MDR expertise required.
- Other info: Fast-paced role with opportunities to work on cutting-edge projects.
The predicted salary is between 36000 - 60000 £ per year.
Our client is an innovative medical device company preparing to submit a De Novo application in the US and gearing up for EU MDR compliance. They are seeking a highly experienced regulatory consultant to oversee and ensure the successful submission of their regulatory applications.
The Senior Regulatory Consultant will provide strategic oversight and hands-on support for the company’s regulatory submissions. The role will involve reviewing prepared documentation, ensuring compliance with all relevant regulatory requirements, and guiding the applications through to successful submission. This is a critical role requiring full lifecycle regulatory experience and a proven track record of successful regulatory placements.
Key Responsibilities- Review and assess regulatory documentation for US De Novo and EU MDR submissions.
- Provide expert guidance on regulatory strategy and submission readiness.
- Ensure all documentation meets regulatory standards and is submission-ready.
- Coordinate with internal teams to address gaps or questions in the prepared applications.
- Support interactions with regulatory authorities as required.
- Oversee and track project timelines to ensure successful submission within the 3–4 month timeframe.
- Proven senior-level regulatory experience in medical devices.
- Extensive experience with US FDA De Novo submissions and EU MDR applications.
- Full lifecycle regulatory expertise, including documentation preparation, submission, and approval.
- Demonstrated success in leading regulatory submissions from start to finish.
- Strong understanding of regulatory standards, guidelines, and best practices.
- Excellent communication and stakeholder management skills.
- Experience working with innovative or early-stage medical device companies.
- Hands-on experience with cross-functional regulatory teams.
Short-term consultancy with high impact on critical regulatory submissions. Opportunity to work on both US and EU regulatory pathways. Collaborate with a motivated, fast-paced team in the medical device sector.
Regulatory Affairs Consultant in London employer: Arevna
Contact Detail:
Arevna Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Consultant in London
✨Tip Number 1
Network like a pro! Reach out to your connections in the medical device industry and let them know you're on the lookout for opportunities. You never know who might have a lead or can introduce you to someone at a company you're interested in.
✨Tip Number 2
Prepare for interviews by brushing up on your regulatory knowledge. Make sure you can discuss US De Novo submissions and EU MDR compliance confidently. We recommend practising common interview questions with a friend or using mock interview tools to get comfortable.
✨Tip Number 3
Showcase your expertise! Create a portfolio that highlights your successful regulatory submissions and projects. This will not only impress potential employers but also give you a chance to discuss your hands-on experience during interviews.
✨Tip Number 4
Don't forget to apply through our website! We have loads of exciting opportunities in the regulatory field, and applying directly can sometimes give you an edge. Plus, it’s super easy to keep track of your applications!
We think you need these skills to ace Regulatory Affairs Consultant in London
Some tips for your application 🫡
Tailor Your Application: Make sure to customise your CV and cover letter for the Regulatory Affairs Consultant role. Highlight your experience with US FDA De Novo submissions and EU MDR applications, as this will show us you’re the right fit for the job.
Showcase Your Experience: We want to see your full lifecycle regulatory expertise! Be specific about your past roles and how you’ve successfully led regulatory submissions from start to finish. This is your chance to shine!
Be Clear and Concise: When writing your application, keep it straightforward. Use clear language and avoid jargon unless it’s relevant to the role. We appreciate a well-structured application that gets straight to the point.
Apply Through Our Website: Don’t forget to submit your application through our website! It’s the best way for us to receive your details and ensures you’re considered for the role. We can’t wait to hear from you!
How to prepare for a job interview at Arevna
✨Know Your Regulations
Make sure you brush up on the latest US FDA De Novo and EU MDR regulations. Being able to discuss specific guidelines and how they apply to the role will show that you're not just familiar with the requirements, but that you can navigate them effectively.
✨Showcase Your Experience
Prepare to share detailed examples of your past regulatory submissions. Highlight your full lifecycle experience and any successful projects you've led. This will demonstrate your capability and give the interviewers confidence in your expertise.
✨Communicate Clearly
Since strong communication skills are essential for this role, practice articulating your thoughts clearly and concisely. Be ready to explain complex regulatory concepts in a way that’s easy to understand, as you may need to coordinate with various internal teams.
✨Ask Insightful Questions
Prepare thoughtful questions about the company’s current projects and challenges in regulatory submissions. This shows your genuine interest in the role and helps you gauge if the company is the right fit for you.