At a Glance
- Tasks: Own and maintain Technical Files, ensuring compliance with EU and international standards.
- Company: Join a leading Medical Device manufacturer focused on your growth.
- Benefits: Fast career progression, supportive team, and collaborative environment.
- Other info: Ideal for those seeking autonomy and collaboration in their role.
- Why this job: Gain real ownership in Regulatory Affairs and make a global impact.
- Qualifications: Degree in life sciences or engineering; understanding of medical device regulations.
The predicted salary is between 30000 - 50000 £ per year.
Regulatory Affairs Associate If you’ve built your foundations in Regulatory Affairs and now want more ownership of submissions, technical documentation and IVDR work, then I may have your next role. I’m working with an established diagnostics business looking for a Regulatory Affairs Specialist to join their team in Cambridge, spanning new registrations, IVDR transition, technical documentation and post market activity. What you’ll be working on: You’ll support the registration and ongoing compliance of IVD products across multiple international markets. Your remit will include: Supporting new product registrations and global regulatory submissions Preparing and maintaining regulatory and technical documentation Supporting the transition of legacy products from IVDD to IVDR Contributing to PMS and lifecycle management for existing IVD products Working across regulated product portfolios Supporting QMS and wider regulatory compliance activities Helping improve the efficiency of regulatory processes and systems What I’m looking for You’ll already have some hands on Regulatory Affairs experience within IVDs, diagnostics or a closely related medical device environment. Ideally, you’ll bring exposure to: Regulatory submissions / product registrations IVDR and/or IVDD Technical documentation Post market surveillance Working within an ISO 13485 QMS You don’t need to have done everything. What matters more is that you understand the fundamentals and want to build broader, hands on regulatory experience rather than stay in a narrow remit. Salary: Up to £45,000 Location: Cambridge, onsite Interested? Apply directly or message me for a confidential conversation.
Regulatory Specialist employer: Medibeam
Medibeam is an excellent employer for those looking to grow within the MedTech industry, offering a supportive culture that prioritises employee development and training. With a well-established ISO 13485 quality management system, employees can expect to gain invaluable experience and skills in QA processes while enjoying the flexibility of a hybrid work model after the initial onboarding period. The company's commitment to fostering talent makes it an ideal place for individuals eager to advance their careers in a meaningful and rewarding environment.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Specialist
✨Tip Number 1
Network like a pro! Reach out to people in the industry, especially those already working in Regulatory Affairs. 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 medical device regulations. Be ready to discuss how you’ve navigated compliance issues in the past. Show them you’re not just a candidate, but a future asset!
✨Tip Number 3
Don’t underestimate the power of follow-ups! After an interview, drop a quick thank-you email to express your appreciation and reiterate your interest. It keeps you fresh in their minds.
✨Tip Number 4
Apply through our website for the best chance at landing that role! We want to see your application and help you get your foot in the door. Plus, it shows you’re serious about joining our team.
We think you need these skills to ace Regulatory Specialist
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Regulatory Specialist role. Highlight your experience with medical device regulations and any relevant projects you've worked on. 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 our team. We love seeing genuine enthusiasm, so let your personality come through!
Showcase Relevant Experience:When detailing your experience, focus on specific examples that demonstrate your understanding of MDD/MDR and technical documentation. We’re keen to see how you’ve navigated challenges in previous roles, so don’t hold back!
Apply Through Our Website:We encourage you to apply directly through our website for the best chance of getting noticed. It streamlines the process for us and ensures your application lands in the right hands. Let’s get you on board!
How to prepare for a job interview at Medibeam
✨Know Your Regulations
Make sure you brush up on the latest medical device regulations, especially MDD/MDR. Being able to discuss these confidently will show that you're not just familiar with the basics but are genuinely engaged with the field.
✨Showcase Your Experience
Prepare specific examples from your past roles where you've managed submissions or worked on technical documentation. This will help demonstrate your hands-on experience and how it aligns with what the company is looking for.
✨Emphasise Collaboration
Since this role values teamwork across various departments, be ready to talk about times when you've successfully collaborated with others. Highlighting your ability to work well with RA, QA, Engineering, and Marketing teams will set you apart.
✨Ask Insightful Questions
Prepare thoughtful questions about the company's approach to regulatory affairs and their expectations for the role. This shows your genuine interest in the position and helps you assess if it's the right fit for you.
