Regulatory Affairs Specialist in London
Regulatory Affairs Specialist

Regulatory Affairs Specialist in London

London Full-Time 45000 - 55000 £ / year (est.) No home office possible
Corin Group

At a Glance

  • Tasks: Support global medical device registrations and regulatory operations for innovative technologies.
  • Company: Join a collaborative team focused on life-changing medical devices.
  • Benefits: Competitive salary, annual bonus, excellent pension, and private medical insurance.
  • Other info: Opportunity to earn bonuses through employee referrals and continuous improvement initiatives.
  • Why this job: Make a real impact in healthcare by working with cutting-edge medical devices.
  • Qualifications: Degree in Life Sciences or Engineering and 4+ years in Regulatory Affairs.

The predicted salary is between 45000 - 55000 £ per year.

We are looking for an experienced Regulatory Affairs Specialist to support global medical device registrations and regulatory operations. You will play a key role in pre- and post-market activities, working on implantable devices and innovative technologies.

What you'll do:

  • Supporting global registrations (CE marking, FDA 510(k))
  • Support correspondence with Regulatory Authorities as required (i.e., prepare additional information or responses as required by regulatory agencies, FDA or NB deficiency responses etc.)
  • Managing regulatory operations such as change controls, IFUs, EUDAMED and MHRA
  • Review protocols & reports and other documentation used to support medical device files
  • Effectively communicate and collaborate with other personnel within the local and global organization
  • Supporting audits and driving continuous improvement initiatives

About you:

  • Degree in Life Sciences, Medical or Engineering
  • 4+ years' experience in medical device Regulatory Affairs
  • Strong knowledge of global regulations and ISO 13485
  • Experience liaising with regulatory authorities (BSI, FDA etc)
  • Familiarity in dealing with and interpreting technical and legislative documentation
  • Detail oriented and excellent written and verbal communication skills

What's in it for you:

  • A competitive salary and a discretionary annual bonus
  • Excellent pension - starts at 6%, going up to 9.7% after 18 months
  • Life assurance - Six times your basic salary
  • Private medical insurance with BUPA for you and your family
  • Free annual eye tests and flu vaccinations
  • Employee referral program where you can earn up to 1,000 for each successful hire you recommend

Apply now to join a collaborative team working on meaningful, life-changing medical devices.

Corin provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

Regulatory Affairs Specialist in London employer: Corin Group

At Corin, we pride ourselves on being an exceptional employer, offering a collaborative work environment where innovation meets purpose. As a Regulatory Affairs Specialist, you will benefit from a competitive salary, generous pension contributions, and comprehensive health coverage, all while contributing to the development of life-changing medical devices. Our commitment to employee growth is evident through continuous improvement initiatives and a supportive culture that values your expertise and input.
Corin Group

Contact Detail:

Corin Group Recruiting Team

StudySmarter Expert Advice 🤫

We think this is how you could land Regulatory Affairs Specialist 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 hunt for a Regulatory Affairs Specialist role. You never know who might have the inside scoop on job openings or can put in a good word for you.

✨Tip Number 2

Prepare for interviews by brushing up on your knowledge of global regulations and ISO 13485. Be ready to discuss how your experience aligns with the requirements of the role, especially your work with CE marking and FDA submissions. Confidence is key!

✨Tip Number 3

Showcase your communication skills! During interviews, highlight examples where you've effectively liaised with regulatory authorities or managed complex documentation. This will demonstrate your ability to handle the responsibilities of the role.

✨Tip Number 4

Don't forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, it shows you're genuinely interested in joining our collaborative team working on life-changing medical devices.

We think you need these skills to ace Regulatory Affairs Specialist in London

Regulatory Affairs
Global Medical Device Registrations
CE Marking
FDA 510(k)
Change Controls Management
IFUs (Instructions for Use)
EUDAMED
MHRA
Protocol Review
Technical Documentation Interpretation
Detail Orientation
Written Communication Skills
Verbal Communication Skills
Knowledge of ISO 13485
Experience with Regulatory Authorities

Some tips for your application 🫡

Tailor Your CV: Make sure your CV is tailored to the Regulatory Affairs Specialist role. Highlight your experience with medical device registrations and any relevant regulatory knowledge. 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 your skills can contribute to our team. Keep it concise but impactful – we love a good story!

Showcase Your Communication Skills: Since this role involves liaising with regulatory authorities, make sure to demonstrate your excellent written communication skills in your application. We appreciate clarity and professionalism, so proofread your documents before sending them our way!

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’re considered for the role. Plus, it’s super easy – just a few clicks and you’re done!

How to prepare for a job interview at Corin Group

✨Know Your Regulations

Make sure you brush up on global regulations and ISO 13485 before the interview. Being able to discuss specific regulations related to medical devices will show that you’re not just familiar with the field, but that you’re also prepared to tackle the challenges of the role.

✨Prepare for Technical Questions

Expect questions about your experience with CE marking and FDA 510(k) submissions. Have examples ready that demonstrate your hands-on experience in managing regulatory operations and how you've successfully navigated audits or regulatory correspondence in the past.

✨Showcase Your Communication Skills

Since the role involves liaising with regulatory authorities, practice articulating complex regulatory concepts clearly and concisely. You might be asked to explain how you would handle a deficiency response, so being able to communicate effectively is key.

✨Demonstrate Attention to Detail

As a Regulatory Affairs Specialist, attention to detail is crucial. Be prepared to discuss how you ensure accuracy in documentation and compliance. You could even bring along examples of protocols or reports you've worked on to illustrate your meticulous approach.

Regulatory Affairs Specialist in London
Corin Group
Location: London

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