At a Glance
- Tasks: Lead regulatory activities for IVD products and ensure compliance across global markets.
- Company: Global leader in life sciences and diagnostics, driving diagnostic innovation.
- Benefits: Remote work, competitive hourly rate, and potential for contract extension.
- Other info: Fast-paced environment with opportunities for collaboration and professional growth.
- Why this job: Join a dynamic team at the forefront of diagnostic innovation and make a real impact.
- Qualifications: Experience in Regulatory Affairs for IVD or medical devices and strong IVDR knowledge.
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.
Regulatory Affairs Manager IVD in Watford employer: Hays Life Sciences
Join a global leader in life sciences and diagnostics, where you will play a pivotal role in advancing innovative diagnostic solutions. Enjoy the flexibility of remote work, competitive hourly rates, and a collaborative culture that fosters professional growth and cross-functional teamwork. With opportunities to engage with regulatory authorities and contribute to impactful projects, this position offers a rewarding career path in a dynamic industry.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Affairs Manager IVD in Watford
✨Tip Number 1
Network like a pro! Reach out to professionals in the regulatory affairs field, especially those working with IVD products. Use platforms like LinkedIn to connect and engage with them; you never know who might have a lead on your dream job!
✨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 and confidence during the interview.
✨Tip Number 3
Don’t just apply anywhere—focus on companies that align with your values and career goals. Check out our website for tailored job listings in regulatory affairs; we’ve got some great opportunities waiting for you!
✨Tip Number 4
Follow up after interviews! A simple thank-you email can go a long way in keeping you top of mind. It shows your enthusiasm for the role and gives you another chance to highlight why you’re the perfect fit for their team.
We think you need these skills to ace Regulatory Affairs Manager IVD in Watford
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 compliance work you've done. We want to see how your skills match 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 in the IVD space. Share specific examples of your past successes and how they relate to the job. We love a good story!
Showcase Your Communication Skills:Since this role involves collaboration with various teams, make sure to highlight your communication skills in your application. We want to know how you’ve effectively worked with cross-functional teams in the past.
Apply Through Our Website:Don’t forget to apply through our website! It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it makes the whole process smoother for everyone involved.
How to prepare for a job interview at Hays Life Sciences
✨Know Your IVDR Inside Out
Make sure you brush up on the IVDR (EU 2017/746) 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’re ready to hit the ground running.
✨Prepare Your Regulatory Success Stories
Think of examples from your past experience where you successfully navigated regulatory submissions or managed compliance issues. Be ready to share these stories, as they’ll 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, Quality, and Clinical, be prepared to discuss how you've effectively collaborated in the past. Highlight any specific projects where teamwork led to successful outcomes, showcasing your communication and stakeholder management skills.
✨Ask Insightful Questions
At the end of the interview, don’t forget to ask questions! Inquire about the company’s approach to regulatory challenges or how they foresee the IVD market evolving. This shows your genuine interest in the role and helps you gauge if the company aligns with your career goals.
