MedTech RAQA Lead: ISO 13485 & 510(k) Strategy in London
MedTech RAQA Lead: ISO 13485 & 510(k) Strategy

MedTech RAQA Lead: ISO 13485 & 510(k) Strategy in London

London Full-Time 55000 - 65000 £ / year (est.) No home office possible
Cure Talent

At a Glance

  • Tasks: Lead Quality and Regulatory functions for innovative wearable medical technology.
  • Company: Dynamic MedTech company in Leicestershire with a focus on growth.
  • Benefits: Competitive salary, opportunities for career advancement, and a vibrant work culture.
  • Other info: Join a high-growth environment where your expertise will drive innovation.
  • Why this job: Make a real impact in healthcare by shaping regulatory strategies for market entry.
  • Qualifications: Strong background in regulatory affairs and experience with FDA submissions.

The predicted salary is between 55000 - 65000 £ per year.

Cure Talent is seeking a RAQA Manager for a wearable medical technology company in Leicestershire, United Kingdom. This pivotal role involves leading the Quality and Regulatory function, implementing ISO 13485 certification and defining US regulatory strategy for market entry.

The ideal candidate has a strong background in regulatory affairs, experience with FDA submissions and ISO 13485 systems, and enjoys working in a high-growth environment.

Competitive salary range of £55,000 to £65,000.

MedTech RAQA Lead: ISO 13485 & 510(k) Strategy in London employer: Cure Talent

Join a dynamic and innovative wearable medical technology company in Leicestershire, where your expertise in regulatory affairs will be valued and impactful. We offer a competitive salary, a collaborative work culture that fosters professional growth, and the opportunity to lead critical projects that shape the future of healthcare technology. With a focus on employee development and a commitment to excellence, this is an ideal environment for those seeking meaningful and rewarding employment.
Cure Talent

Contact Detail:

Cure Talent Recruiting Team

StudySmarter Expert Advice 🤫

We think this is how you could land MedTech RAQA Lead: ISO 13485 & 510(k) Strategy in London

✨Tip Number 1

Network like a pro! Reach out to industry professionals on LinkedIn or attend local MedTech events. We can’t stress enough how personal connections can open doors that applications alone can’t.

✨Tip Number 2

Prepare for interviews by researching the company’s products and recent news. Show us you’re genuinely interested in their mission and how your experience with ISO 13485 and FDA submissions can make a difference.

✨Tip Number 3

Practice your pitch! Be ready to explain how your background aligns with the role of RAQA Manager. We want to hear how you can lead the Quality and Regulatory function effectively.

✨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 take the initiative to connect directly with us.

We think you need these skills to ace MedTech RAQA Lead: ISO 13485 & 510(k) Strategy in London

Regulatory Affairs
ISO 13485
FDA Submissions
Quality Management Systems
Market Entry Strategy
Leadership Skills
High-Growth Environment Adaptability
Project Management

Some tips for your application 🫡

Tailor Your CV: Make sure your CV is tailored to the RAQA Manager role. Highlight your experience with ISO 13485 and FDA submissions, as these are key for us. Use specific examples that showcase your skills in regulatory affairs.

Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Tell us why you're passionate about MedTech and how your background aligns with our needs. Be sure to mention your experience in high-growth environments, as we value that here at StudySmarter.

Showcase Your Achievements: Don’t just list your responsibilities; showcase your achievements! Use metrics where possible to demonstrate how you’ve successfully implemented ISO 13485 systems or led FDA submissions. We love seeing tangible results!

Apply Through Our Website: We encourage you to apply through our website for a smoother process. It helps us keep track of your application and ensures you don’t miss out on any important updates. Plus, it’s super easy!

How to prepare for a job interview at Cure Talent

✨Know Your ISO 13485 Inside Out

Make sure you’re well-versed in ISO 13485 standards. Brush up on the key requirements and how they apply to the role. Being able to discuss specific examples of how you've implemented these standards in past roles will show your expertise.

✨Familiarise Yourself with FDA Submissions

Since this role involves defining US regulatory strategy, it’s crucial to understand the FDA submission process. Prepare to discuss any previous experiences you have with 510(k) submissions and how you navigated challenges during those processes.

✨Show Your Passion for MedTech

This is a high-growth environment, so demonstrate your enthusiasm for wearable medical technology. Share insights about recent trends or innovations in the field and how they could impact the company’s strategy.

✨Prepare Questions That Matter

Think of insightful questions to ask during the interview. Inquire about the company's future plans regarding regulatory changes or how they plan to scale their operations. This shows that you’re not just interested in the role but also in the company’s vision.

MedTech RAQA Lead: ISO 13485 & 510(k) Strategy in London
Cure Talent
Location: London

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