At a Glance
- Tasks: Lead regulatory activities for innovative IVD products across global markets.
- Company: Global leader in life sciences and diagnostics, pioneering diagnostic innovation.
- Benefits: Remote work, competitive hourly rate, and potential for contract extension.
- Other info: Fast-paced environment with opportunities for career growth and collaboration.
- Why this job: Join a dynamic team and ensure compliance in cutting-edge diagnostic solutions.
- Qualifications: Experience in Regulatory Affairs for IVD or medical devices is essential.
The predicted salary is between 40000 - 50000 € per year.
Our client, a global leader in life sciences and diagnostics, is seeking an experienced Regulatory Affairs Manager to support their expanding IVD portfolio on a contract basis. This is a fantastic opportunity to work at the forefront of diagnostic innovation, ensuring regulatory compliance across key markets.
Your new role:
- Lead and support regulatory activities for IVD products across global markets (EU, UK, and potentially US/ROW)
- Prepare, review, and submit regulatory documentation (e.g., IVDR technical files, submissions, change notifications)
- Provide strategic regulatory guidance throughout the product lifecycle
- Collaborate cross-functionally with R&D, Quality, Clinical, and Commercial teams
- Ensure compliance with IVDR (EU 2017/746) and other applicable regulations
- Support audits, inspections, and interactions with notified bodies and regulatory authorities.
What you'll need to succeed:
- Proven experience in Regulatory Affairs within IVD or medical devices
- Strong working knowledge of IVDR requirements (essential)
- Experience preparing and managing regulatory submissions and technical documentation
- Ability to work in a fast-paced, cross-functional global environment
- Excellent communication and stakeholder management skills
- Degree in a scientific or related discipline preferred
What you'll get in return:
- Remote working, good hourly rate, scope for extension
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now. If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion about your career.
Regulatory Affairs Manager IVD employer: Hays Life Sciences
Join a global leader in life sciences and diagnostics as a Regulatory Affairs Manager, where you will play a pivotal role in driving innovation in IVD products. Enjoy the flexibility of remote working, competitive hourly rates, and the opportunity for career growth while collaborating with cross-functional teams in a dynamic and supportive work culture that values compliance and excellence.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Affairs Manager IVD
✨Tip Number 1
Network like a pro! Reach out to your connections in the regulatory affairs space, especially those who have experience with IVD products. A friendly chat can lead to insider info about job openings or even referrals.
✨Tip Number 2
Prepare for interviews by brushing up on IVDR requirements and recent changes in regulations. We recommend creating a cheat sheet of key points to discuss, so you can showcase your expertise confidently.
✨Tip Number 3
Don’t just apply blindly! Tailor your approach for each application. Highlight your relevant experience in regulatory submissions and compliance in your conversations, showing how you can add value to their team.
✨Tip Number 4
Keep an eye on our website for the latest job postings. We often have exciting opportunities that might not be advertised elsewhere, so make sure to check back regularly!
We think you need these skills to ace Regulatory Affairs Manager IVD
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Regulatory Affairs Manager role. Highlight your experience with IVD products and any relevant regulatory submissions you've managed. We want to see how your skills match what we're looking for!
Showcase Your Knowledge:Don’t forget to showcase your understanding of IVDR requirements in your application. Mention specific regulations or guidelines you’ve worked with, as this will show us you’re the right fit for the job.
Be Clear and Concise:When writing your cover letter, keep it clear and concise. We appreciate straightforward communication, so get to the point while still showing your enthusiasm for the role and the company.
Apply Through Our Website:We encourage you to apply through our website for a smoother 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 Hays Life Sciences
✨Know Your IVDR Inside Out
Make sure you brush up on the IVDR requirements before your interview. Being able to discuss specific regulations and how they apply to IVD products will show that you're not just familiar with the basics, but that you truly understand the landscape.
✨Prepare Your Regulatory Success Stories
Think of examples from your past experience where you've successfully navigated regulatory submissions or compliance challenges. Be ready to share these stories, as they demonstrate your hands-on expertise and problem-solving skills in a real-world context.
✨Cross-Functional Collaboration is Key
Since the role involves working with various teams like R&D and Quality, be prepared to discuss how you've effectively collaborated with different departments in the past. Highlighting your communication skills and teamwork will resonate well with the interviewers.
✨Ask Insightful Questions
At the end of the interview, don’t forget to ask questions that show your interest in the company and the role. Inquire about their current IVD projects or how they handle regulatory changes. This not only shows your enthusiasm but also helps you gauge if the company is the right fit for you.
