At a Glance
- Tasks: Develop and maintain a Quality Management System for medical devices.
- Company: Abbexa, a leader in medical device compliance.
- Benefits: Competitive salary, 21 days holiday, and healthcare package.
- Other info: Full-time position based in Bar Hill with great career growth.
- Why this job: Join a dynamic team ensuring compliance with evolving regulations.
- Qualifications: 2 years experience in a regulated environment and knowledge of IVDR processes.
The predicted salary is between 35000 - 45000 € per year.
Abbexa is seeking a Regulatory Affairs Officer to develop and maintain a Quality Management System compliant with ISO 13485 for medical devices. The role involves overseeing regulatory submissions for UK and EU product development and ensuring compliance with evolving regulations.
The ideal candidate should have at least 2 years of experience in a regulated environment, knowledge of IVDR processes, and excellent organizational skills.
This full-time position is based in Bar Hill and offers competitive benefits, including 21 days holiday and a healthcare package.
Regulatory Affairs Officer: IVDR/ISO 13485 Expert employer: Abbexa
Abbexa is an excellent employer that fosters a collaborative and innovative work culture, ideal for professionals looking to make a meaningful impact in the medical device industry. Located in Bar Hill, employees benefit from competitive perks such as 21 days of holiday and a comprehensive healthcare package, alongside ample opportunities for personal and professional growth within a supportive team environment.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Affairs Officer: IVDR/ISO 13485 Expert
✨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 ISO 13485 and IVDR processes. We recommend creating a cheat sheet of key points to discuss, so you can impress the hiring managers with your expertise.
✨Tip Number 3
Showcase your organisational skills! During interviews, share examples of how you've successfully managed projects or submissions in the past. We want to see how you can bring that experience to Abbexa.
✨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 engage directly with us.
We think you need these skills to ace Regulatory Affairs Officer: IVDR/ISO 13485 Expert
Some tips for your application 🫡
Tailor Your CV:Make sure your CV highlights your experience in regulatory affairs, especially with ISO 13485 and IVDR processes. We want to see how your skills match the job description, so don’t be shy about showcasing relevant projects!
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 Abbexa. Keep it concise but engaging – we love a good story!
Showcase Your Organisational Skills:Since this role requires excellent organisational skills, give examples in your application of how you've successfully managed multiple projects or deadlines in the past. We want to see that you can keep everything on track!
Apply Through Our Website:We encourage you to apply directly through our website. It’s the easiest way for us to receive your application and ensures you don’t miss out on any important updates. Plus, we love seeing applications come in through our own platform!
How to prepare for a job interview at Abbexa
✨Know Your Regulations
Make sure you brush up on the latest IVDR and ISO 13485 regulations. Being able to discuss these in detail will show that you’re not just familiar with the standards, but that you can apply them practically in a regulatory environment.
✨Showcase Your Experience
Prepare specific examples from your past roles where you successfully managed regulatory submissions or developed quality management systems. This will help demonstrate your hands-on experience and problem-solving skills in a regulated setting.
✨Organisational Skills Matter
Since the role requires excellent organisational skills, be ready to discuss how you prioritise tasks and manage multiple projects. Consider sharing a time when your organisational skills led to a successful outcome in a previous job.
✨Ask Insightful Questions
Prepare thoughtful questions about Abbexa’s current projects or challenges they face in regulatory affairs. This shows your genuine interest in the company and helps you assess if it’s the right fit for you.
