At a Glance
- Tasks: Support regulatory compliance for medical devices and manage submissions.
- Company: Join Abbexa, a leader in medical device innovation in Cambridge.
- Benefits: Enjoy healthcare benefits and 21 days of holiday.
- Other info: Full-time role with opportunities for professional growth.
- Why this job: Make a difference in healthcare by ensuring product compliance.
- Qualifications: Experience with EU IVDR regulations and ISO 13485 required.
The predicted salary is between 35000 - 45000 £ per year.
Job Search Place Limited is seeking a Regulatory Affairs Officer to support the regulatory compliance for products at Abbexa in Bar Hill, Cambridge. The role entails developing and maintaining a compliant Quality Management System and managing regulatory submissions.
The ideal candidate has proven experience with EU IVDR regulations and ISO 13485, and at least 2 years of working in a regulated medical device environment.
This full-time position offers comprehensive benefits, including healthcare and 21 days of holiday.
Regulatory Affairs Officer — PRRC, IVDR & CE (Medical Devices) in Cambridge employer: Job Search Place Limited
At Abbexa in Bar Hill, Cambridge, we pride ourselves on being an excellent employer that fosters a collaborative and innovative work culture. Our commitment to employee growth is evident through ongoing training opportunities and a supportive environment that encourages professional development. With comprehensive benefits including healthcare and generous holiday allowances, we ensure our team members feel valued and motivated in their roles.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Affairs Officer — PRRC, IVDR & CE (Medical Devices) in Cambridge
✨Tip Number 1
Network like a pro! Reach out to professionals in the regulatory affairs field on LinkedIn or at industry events. We can’t stress enough how valuable personal connections can be in landing that dream job.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of EU IVDR regulations and ISO 13485. We recommend creating a cheat sheet with key points to discuss, so you can impress the hiring managers with your expertise.
✨Tip Number 3
Showcase your experience! When you get the chance to chat with potential employers, highlight your past roles in regulated medical device environments. We want to see how your background aligns with their needs.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. We’re here to help you every step of the way, so let’s get you that Regulatory Affairs Officer position!
We think you need these skills to ace Regulatory Affairs Officer — PRRC, IVDR & CE (Medical Devices) in Cambridge
Some tips for your application 🫡
Tailor Your CV:Make sure your CV highlights your experience with EU IVDR regulations and ISO 13485. We want to see how your background aligns with the role, so don’t be shy about showcasing relevant projects or achievements!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you’re passionate about regulatory affairs in the medical device sector and how your skills can help us at Abbexa. Keep it concise but impactful!
Showcase Your Compliance Knowledge:Since this role involves managing regulatory submissions, make sure to mention any specific experiences you have in this area. We love candidates who can demonstrate their understanding of compliance processes and quality management systems.
Apply Through Our Website:We encourage you to apply directly through our website for a smoother application process. It helps us keep track of your application and ensures you don’t miss out on any important updates from us!
How to prepare for a job interview at Job Search Place Limited
✨Know Your Regulations
Make sure you brush up on EU IVDR regulations and ISO 13485 before the interview. Being able to discuss these in detail will show that you’re not just familiar with them, but that you can apply this knowledge practically.
✨Showcase Your Experience
Prepare specific examples from your past roles where you successfully managed regulatory submissions or developed a Quality Management System. This will help demonstrate your hands-on experience in a regulated medical device environment.
✨Ask Insightful Questions
Think of questions that show your interest in Abbexa’s products and their compliance processes. Asking about their current challenges with regulatory affairs can highlight your proactive approach and genuine interest in the role.
✨Dress the Part
Even if the company culture is relaxed, dressing professionally can make a great first impression. It shows that you take the opportunity seriously and respect the interview process.
