Regulatory Affairs Lead – Medical Devices (IVDR/CE) in London

Regulatory Affairs Lead – Medical Devices (IVDR/CE) in London

London Full-Time 40000 - 50000 € / year (est.) No home office possible
Abbexa Ltd

At a Glance

  • Tasks: Ensure compliance with UK/EU regulations for medical devices and guide products to market launch.
  • Company: Abbexa Ltd, a forward-thinking company in the medical device sector.
  • Benefits: 21 days holiday, healthcare benefits, and a pension scheme.
  • Other info: Commitment to equality and a supportive work culture.
  • Why this job: Join a team making a difference in healthcare and ensure product safety.
  • Qualifications: 2+ years' experience in a regulated environment and knowledge of EU IVDR.

The predicted salary is between 40000 - 50000 € per year.

Abbexa Ltd is seeking a full-time Regulatory Affairs Officer in Bar Hill, Cambridge. In this role, you'll ensure compliance with UK/EU regulations for medical devices, guiding products through market launch.

Ideal candidates will have 2+ years' experience in a regulated environment and a deep understanding of the EU IVDR assessment process.

Abbexa offers a commitment to equality, 21 days holiday, healthcare benefits, and a pension scheme.

Regulatory Affairs Lead – Medical Devices (IVDR/CE) in London employer: Abbexa Ltd

Abbexa Ltd is an excellent employer that prioritises equality and employee well-being, offering a supportive work culture in the vibrant area of Bar Hill, Cambridge. With a commitment to professional growth, employees benefit from comprehensive healthcare, a pension scheme, and generous holiday allowances, making it an ideal place for those looking to advance their careers in regulatory affairs within the medical devices sector.

Abbexa Ltd

Contact Detail:

Abbexa Ltd Recruiting Team

StudySmarter Expert Advice🀫

We think this is how you could land Regulatory Affairs Lead – Medical Devices (IVDR/CE) in London

✨Tip Number 1

Network like a pro! Reach out to professionals in the regulatory affairs field, especially those who have experience with medical devices. 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 UK/EU regulations and the IVDR assessment process. We recommend creating a cheat sheet of key points to discuss, so you can confidently showcase your expertise when it counts.

✨Tip Number 3

Practice makes perfect! Conduct mock interviews with friends or mentors to refine your answers and get comfortable discussing your experience in a regulated environment. This will help you stand out as a candidate who knows their stuff.

✨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 engage directly with us.

We think you need these skills to ace Regulatory Affairs Lead – Medical Devices (IVDR/CE) in London

Regulatory Compliance
EU IVDR Assessment Process
Medical Device Regulations
Market Launch Strategies
Experience in Regulated Environment
Attention to Detail
Communication Skills

Some tips for your application 🫑

Tailor Your CV:Make sure your CV is tailored to the Regulatory Affairs Lead role. Highlight your experience in a regulated environment and any specific knowledge of the EU IVDR assessment process. We want to see how your background aligns with what we're looking for!

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 you can contribute to Abbexa. We love seeing candidates who can connect their personal motivations to our mission.

Showcase Relevant Experience:When filling out your application, be sure to showcase any relevant experience you have with medical devices and compliance. We’re keen on candidates who can demonstrate their understanding of UK/EU regulations, so don’t hold back!

Apply Through Our Website:We encourage you to apply through our website for a smoother process. It helps us keep track of applications and ensures you get all the updates directly from us. Plus, it’s super easy!

How to prepare for a job interview at Abbexa Ltd

✨Know Your Regulations

Make sure you brush up on the UK/EU regulations for medical devices, especially the IVDR assessment process. Being able to discuss specific regulations and how they apply to Abbexa's products will show that you're not just familiar with the field, but that you’re ready to hit the ground running.

✨Showcase Your Experience

With 2+ years in a regulated environment, be prepared to share concrete examples of your past work. Highlight any successful product launches or compliance challenges you've navigated. This will demonstrate your hands-on experience and problem-solving skills.

✨Ask Insightful Questions

Prepare thoughtful questions about Abbexa’s current projects or future plans regarding regulatory affairs. This shows your genuine interest in the role and helps you understand how you can contribute to their success.

✨Cultural Fit Matters

Research Abbexa’s company culture and values. Be ready to discuss how your personal values align with theirs, especially regarding equality and teamwork. This can set you apart as a candidate who not only has the skills but also fits well within their team.