At a Glance
- Tasks: Support global medical device registrations and regulatory operations for innovative technologies.
- Company: Join a collaborative team at Corin, focused on life-changing medical devices.
- Benefits: Competitive salary, annual bonus, excellent pension, and private medical insurance.
- Other info: Enjoy a dynamic work environment with opportunities for continuous improvement.
- Why this job: Make a real impact in healthcare by working on cutting-edge medical devices.
- Qualifications: Degree in Life Sciences or Engineering with 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.
UK - Regulatory Affairs Specialist employer: Corin Group
Corin is an exceptional employer, offering a collaborative work environment where you can contribute to the development of life-changing medical devices. With a strong focus on employee growth, competitive salaries, and comprehensive benefits including private medical insurance and generous pension contributions, Corin ensures that its team members are well-supported both professionally and personally. Located in the UK, this role provides the unique opportunity to engage with global regulatory affairs while being part of a company that values diversity and equal opportunities.
StudySmarter Expert Advice🤫
We think this is how you could land UK - Regulatory Affairs Specialist
✨Tip Number 1
Network like a pro! Reach out to your connections in the regulatory affairs field, especially those who have experience with medical devices. A friendly chat can lead to insider info about job openings or even a referral.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of global regulations and ISO 13485. We recommend practising common interview questions related to regulatory affairs so you can showcase your expertise confidently.
✨Tip Number 3
Don’t underestimate the power of follow-ups! After an interview, send a thank-you email to express your appreciation and reiterate your interest in the role. It keeps you fresh in their minds and shows your enthusiasm.
✨Tip Number 4
Apply through our website for the best chance at landing that Regulatory Affairs Specialist role. We keep our listings updated, and applying directly can sometimes give you an edge over other candidates!
We think you need these skills to ace UK - Regulatory Affairs Specialist
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 hitting send!
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 follow the prompts!
How to prepare for a job interview at Corin Group
✨Know Your Regulations
Make sure you brush up on the latest global regulations and standards, especially ISO 13485. Being able to discuss these in detail will show your expertise and confidence in regulatory affairs.
✨Prepare for Technical Questions
Expect questions about specific regulatory processes like CE marking and FDA 510(k) submissions. Prepare examples from your past experience where you've successfully navigated these processes to demonstrate your hands-on knowledge.
✨Showcase Your Communication Skills
Since you'll be liaising with regulatory authorities, practice articulating complex information clearly and concisely. Use examples of how you've effectively communicated with stakeholders in previous roles to highlight your skills.
✨Demonstrate Continuous Improvement Mindset
Be ready to discuss how you've contributed to audits or improvement initiatives in your past roles. This shows that you're not just about compliance but also about enhancing processes and driving quality.
