Senior Clinical Submission Specialist, IVDR in Manchester

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. 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.

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).

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.