Senior Clinical Submission Specialist, IVDR
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Overview
At QIAGEN, we are driven by a simple but powerful vision: making improvements in life possible.
We’re 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. We’re always striving to identify talented individuals to join our exceptional teams.
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.
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 high‑quality clinical submission documentation for in vitro diagnostic (IVD) products, ensuring compliance with applicable global regulatory requirements.
This role requires strong attention to detail, cross‑functional 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 58–77 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 cross‑functionally 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
Bachelor’s degree in Life Sciences, Biomedical Sciences, or a related discipline (Master’s 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.