Find a job 
Featured Companies 
Featured Universities 
For Companies At a Glance
- Tasks: Prepare and manage clinical submissions for innovative IVD products in a dynamic environment.
- Company: Join QIAGEN, a global leader in science and healthcare innovation.
- Benefits: Enjoy flexible working, private healthcare, gym contributions, and 25 days annual leave.
- Other info: Thriving culture that values diversity and encourages entrepreneurial thinking.
- Why this job: Make a real impact in healthcare while collaborating with talented professionals.
- Qualifications: Bachelor's in Life Sciences; experience in clinical documentation and regulatory submissions preferred.
The predicted salary is between 40000 - 50000 ÂŁ per year.
Overview
At QIAGEN, we are driven by a simple but powerful vision: making improvements in life possible. Weâre dedicated to revolutionizing science and healthcare for the better. From our entrepreneurial roots to our current global presence, we've grown into a force for positive change. With thousands of employees across six continents, collaboration is our greatest strength. Weâre always striving to identify talented individuals to join our exceptional teams. At QIAGEN, every day is an opportunity to make a real-life impact. Join us, grow with us, and together, let's shape the future of biological discovery.
About the opportunity
We are seeking a Senior Clinical Submission Specialist to join our Clinical Affairs organisation in Manchester. The successful candidate will support the preparation, compilation, and maintenance of highâquality clinical submission documentation for in vitro diagnostic (IVD) products, ensuring compliance with applicable global regulatory requirements. This role requires strong attention to detail, crossâfunctional collaboration, and a solid understanding of clinical and regulatory submission processes.
Your tasks
- Prepare, compile, and manage clinical trial applications and notifications for IVDR performance studies in EU Member States (per Articles 58â77 of IVDR), including initial submissions, amendments, notifications and reporting obligations.
- Coordinate authorisation and notification processes with Competent Authorities, Ethics Committees, and internal and external stakeholders.
- Ensure submission packages are complete, accurate, and compliant with EU IVDR, national requirements, and internal procedures.
- Act as the clinical submission point of contact for EU performance study documentation, timelines, and tracking.
- Support responses to Competent Authority and Ethics Committee questions related to performance study submissions.
- Maintain submission documentation and correspondence in applicable document management and tracking systems.
- Collaborate crossâfunctionally with Clinical Operations, Regulatory Affairs, Quality, Legal, and R&D to ensure aligned and timely submissions.
- Contribute to the continuous improvement of clinical submission workflows and templates related to IVDR performance studies.
Your profile
- Bachelorâs degree in Life Sciences, Biomedical Sciences, or a related discipline (Masterâs degree preferred).
- Experience in clinical documentation, regulatory submissions, or clinical affairs within the IVD or medical device industry.
- Knowledge of EU IVDR clinical/performance evaluation requirements.
- Strong written communication skills with experience in scientific/clinical writing.
- High level of attention to detail and document quality including proficiency with document management systems and Microsoft Office tools.
- Strong collaboration and stakeholder management skills with the ability to manage multiple priorities and timelines.
- Comfortable working in a regulated environment.
What we offer
- Attractive pension.
- Private Healthcare and Dentalcare.
- Gym membership contribution.
- A range of retail discounts and offers.
- Enhanced maternity package.
- Flexible working options.
- Bonus/commission.
- 25 days annual leave (potential to increase linked to service).
- Employee Assistance Program and internal QIAGEN communities.
- Hybrid work (conditional to your role).
Our people are the heartbeat of everything we do. Passion drives us as we push boundaries to innovate and evolve. We inspire with our leadership and make an impact with our actions. We cultivate a collaborative, supportive environment where each individual and team can flourish. We champion accountability and encourage entrepreneurial thinking. QIAGEN is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, or disability. We have played a pivotal role in shaping modern science and healthcare, and we're just getting started. If you're someone who thrives on new challenges, values diversity and wants to make a tangible difference in people's lives, then QIAGEN is the place for you.
Senior Clinical Submission Specialist, IVDR employer: Qiagen N.V
Contact Detail:
Qiagen N.V Recruiting Team
StudySmarter Expert Advice đ¤Ť
We think this is how you could land Senior Clinical Submission Specialist, IVDR
â¨Tip Number 1
Network like a pro! Reach out to current or former employees at QIAGEN on LinkedIn. A friendly chat can give you insider info and might even lead to a referral, which is always a bonus!
â¨Tip Number 2
Prepare for the interview by brushing up on your knowledge of EU IVDR regulations. Show us that youâre not just familiar with the requirements but also passionate about making a real impact in the field.
â¨Tip Number 3
Practice your STAR technique for answering behavioural questions. We want to hear about specific situations where you demonstrated strong collaboration and attention to detailâso have those stories ready!
â¨Tip Number 4
Donât forget to apply through our website! Itâs the best way to ensure your application gets seen by the right people. Plus, it shows youâre genuinely interested in joining our team at QIAGEN.
We think you need these skills to ace Senior Clinical Submission Specialist, IVDR
Some tips for your application đŤĄ
Tailor Your Application: Make sure to customise your CV and cover letter for the Senior Clinical Submission Specialist role. Highlight your experience in clinical documentation and regulatory submissions, as this will show us you understand what we're looking for.
Showcase Your Attention to Detail: Since this role requires a high level of attention to detail, include examples in your application that demonstrate your meticulousness. Whether it's a project you managed or a document you prepared, let us see how you ensure quality.
Highlight Collaboration Skills: We love teamwork at QIAGEN! In your application, mention any cross-functional projects you've worked on. This will help us see how you can fit into our collaborative environment and contribute to our goals.
Apply Through Our Website: For the best chance of success, make sure to apply directly through our website. This way, your application will be seen by the right people, and you'll be one step closer to joining our amazing team!
How to prepare for a job interview at Qiagen N.V
â¨Know Your IVDR Inside Out
Make sure you brush up on the EU In Vitro Diagnostic Regulation (IVDR) before your interview. Understanding the key articles and requirements will not only show your expertise but also demonstrate your commitment to compliance and quality in clinical submissions.
â¨Showcase Your Collaboration Skills
Since this role involves cross-functional collaboration, be ready to share examples of how you've successfully worked with different teams in the past. Highlight your ability to manage multiple priorities and timelines while keeping everyone aligned.
â¨Prepare for Technical Questions
Expect questions about your experience with clinical documentation and regulatory submissions. Be prepared to discuss specific projects you've worked on, the challenges you faced, and how you ensured compliance with regulatory requirements.
â¨Demonstrate Attention to Detail
Given the importance of accuracy in submission packages, be ready to discuss how you maintain high standards in your work. You might want to mention any tools or systems you use to ensure document quality and compliance.