Regulatory Affairs Manager: EU MDR Strategy for Class III

Regulatory Affairs Manager: EU MDR Strategy for Class III

Full-Time 60000 - 80000 £ / year (est.) No working from home possible
Cure Talent

At a Glance

  • Tasks: Lead the EU regulatory strategy for a new Class III medical device and define approval pathways.
  • Company: Join a globally recognised organisation making a difference in healthcare.
  • Benefits: Significant long-term progression potential and collaborative work environment.
  • Other info: Collaborate with R&D and Clinical teams to ensure compliance and success.
  • Why this job: Make a real impact in the medical device industry with your expertise.
  • Qualifications: Proven experience in medical device regulatory affairs, especially with Class III products.

The predicted salary is between 60000 - 80000 £ per year.

Cure Talent is seeking a Regulatory Affairs Manager to lead the EU Regulatory Strategy for a new Class III medical device. This role involves defining approval pathways under MDR 2017/745 and leading regulatory strategy development from early stages to approval.

The ideal candidate will have proven experience in medical device regulatory affairs, specifically with Class III products, and will successfully collaborate across R&D and Clinical teams to ensure compliance and success of the regulatory program.

This high-impact role offers significant long-term progression potential within a globally recognized organization.

Regulatory Affairs Manager: EU MDR Strategy for Class III employer: Cure Talent

Cure Talent is an exceptional employer, offering a dynamic work culture that fosters collaboration and innovation in the medical device sector. With a strong commitment to employee growth, we provide ample opportunities for professional development and career advancement within our globally recognised organisation. Join us in a role that not only challenges you but also allows you to make a meaningful impact on healthcare outcomes across Europe.

Cure Talent

Contact Details:

Cure Talent Recruitment Team

StudySmarter Expert Advice🤫

We think this is how you could land Regulatory Affairs Manager: EU MDR Strategy for Class III

Tip Number 1

Network like a pro! Reach out to professionals in the regulatory affairs field, especially those who have experience with Class III medical devices. Attend industry events or webinars to make connections and learn about potential job openings.

Tip Number 2

Prepare for interviews by brushing up on EU MDR regulations and recent changes. We want you to be able to discuss how your experience aligns with the role and how you can contribute to the success of the regulatory strategy.

Tip Number 3

Showcase your collaboration skills! Since this role involves working closely with R&D and Clinical teams, be ready to share examples of how you've successfully worked in cross-functional teams in the past.

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 about their job search!

We think you need these skills to ace Regulatory Affairs Manager: EU MDR Strategy for Class III

Regulatory Strategy Development
EU MDR 2017/745 Knowledge
Medical Device Regulatory Affairs
Class III Product Expertise
Collaboration Skills
Compliance Management
Project Management

Some tips for your application 🫡

Tailor Your CV:Make sure your CV highlights your experience in regulatory affairs, especially with Class III medical devices. We want to see how your background aligns with the role, so don’t be shy about showcasing relevant projects and achievements!

Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you’re passionate about regulatory affairs and how your skills can help us navigate the EU MDR landscape. Be specific about your experience and how it relates to the job.

Showcase Collaboration Skills:Since this role involves working closely with R&D and Clinical teams, make sure to highlight any past experiences where you successfully collaborated across departments. We love seeing teamwork in action!

Apply Through Our Website:We encourage you to apply directly through our website for a smoother application process. It helps us keep everything organised and ensures your application gets the attention it deserves!

How to prepare for a job interview at Cure Talent

Know Your MDR Inside Out

Make sure you’re well-versed in the EU MDR 2017/745 regulations. Brush up on the specific approval pathways for Class III medical devices, as this will show your expertise and readiness to tackle the role head-on.

Showcase Your Collaborative Spirit

Since this role involves working closely with R&D and Clinical teams, be prepared to discuss examples of how you've successfully collaborated in the past. Highlight your communication skills and ability to bridge gaps between different departments.

Prepare for Scenario-Based Questions

Expect questions that assess your problem-solving skills in real-world regulatory scenarios. Think about challenges you've faced in previous roles and how you navigated them, especially regarding Class III products.

Express Your Vision for Regulatory Strategy

Be ready to articulate your vision for developing a regulatory strategy for a new Class III device. Discuss how you would approach the early stages of the process and what key factors you would consider to ensure compliance and success.