Regulatory Affairs Specialist — Medical Devices (MDR/FDA)

Regulatory Affairs Specialist — Medical Devices (MDR/FDA)

Full-Time 40000 - 55000 £ / year (est.) No working from home possible
Broughton Group

At a Glance

  • Tasks: Support regulatory activities and ensure compliance with medical device standards.
  • Company: Join Broughton Group, a leader in the medical device industry.
  • Benefits: Competitive salary, professional development, and a supportive team environment.
  • Other info: Exciting opportunity for growth in a dynamic regulatory landscape.
  • Why this job: Make a difference in healthcare by ensuring product safety and compliance.
  • Qualifications: Experience in Regulatory Affairs and strong organisational skills required.

The predicted salary is between 40000 - 55000 £ per year.

Broughton Group is seeking a Regulatory Affairs Specialist to join their Quality & Regulatory team in Greater London. This role involves supporting regulatory activities across the product lifecycle, ensuring compliance with regulatory standards including ISO 13485, MDR, and FDA.

The ideal candidate will have proven experience in Regulatory Affairs within the medical device industry and be adept at managing technical documentation and regulatory submissions. Strong organisational skills and attention to detail are essential for success.

Regulatory Affairs Specialist — Medical Devices (MDR/FDA) employer: Broughton Group

Broughton Group is an excellent employer, offering a dynamic work culture that fosters collaboration and innovation within the Quality & Regulatory team. Employees benefit from comprehensive professional development opportunities, competitive remuneration, and a supportive environment that values attention to detail and organisational skills, making it an ideal place for those passionate about regulatory affairs in the medical device industry in Greater London.

Broughton Group

Contact Details:

Broughton Group Recruitment Team

StudySmarter Expert Advice🤫

We think this is how you could land Regulatory Affairs Specialist — Medical Devices (MDR/FDA)

Tip Number 1

Network like a pro! Reach out to professionals in the medical device industry on LinkedIn or at local events. We can’t stress enough how valuable connections can be when it comes to landing that Regulatory Affairs Specialist role.

Tip Number 2

Prepare for interviews by brushing up on your knowledge of ISO 13485, MDR, and FDA regulations. We recommend creating a cheat sheet of key points to discuss, so you can impress your interviewers with your expertise!

Tip Number 3

Showcase your organisational skills! During interviews, share examples of how you've managed technical documentation and regulatory submissions in the past. We want to see how you handle the nitty-gritty details that are crucial in this field.

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 Regulatory Affairs Specialist — Medical Devices (MDR/FDA)

Regulatory Affairs
ISO 13485
MDR
FDA
Technical Documentation Management
Regulatory Submissions
Organisational Skills

Some tips for your application 🫡

Tailor Your CV:Make sure your CV highlights your experience in Regulatory Affairs, especially within the medical device industry. We want to see how your skills align with the requirements like ISO 13485, MDR, and FDA compliance.

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 background makes you the perfect fit for our team at Broughton Group.

Showcase Your Organisational Skills:Since strong organisational skills are key for this role, consider including examples of how you've successfully managed technical documentation or regulatory submissions in the past. We love seeing real-life applications!

Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you don’t miss any important updates from our team!

How to prepare for a job interview at Broughton Group

Know Your Regulations

Make sure you brush up on ISO 13485, MDR, and FDA regulations before the interview. Being able to discuss these standards confidently will show that you’re not just familiar with them but can also apply them in real-world scenarios.

Showcase Your Documentation Skills

Prepare examples of your experience managing technical documentation and regulatory submissions. Bring along samples or be ready to discuss specific challenges you faced and how you overcame them. This will highlight your organisational skills and attention to detail.

Research Broughton Group

Take some time to learn about Broughton Group’s products and their approach to regulatory affairs. Understanding their specific needs and challenges will allow you to tailor your answers and demonstrate your genuine interest in the role.

Prepare Questions

Have a few thoughtful questions ready to ask at the end of the interview. This could be about their current projects, team dynamics, or future regulatory challenges. It shows that you’re engaged and thinking ahead about how you can contribute.