Clinical Science Manager
4 tygodni temu
Overview
At QIAGEN, we are driven by a vision to make improvements in life possible. Our mission is to make a real difference in science and healthcare, and we are constantly looking for talented individuals to join our team.
Position Description
This role within the Clinical Science team of Clinical Affairs will serve as a Clinical Expert contributing towards gathering clinical evidence and presenting it to regulatory bodies in support of the In-vitro Diagnostic (IVD) product range within QIAGEN, primarily focused on the Oncology and Companion Diagnostics portfolio.
Key Responsibilities
Manage the delivery of clinical/performance evaluation plans, scientific validity reports, and clinical/performance evaluation reports to support Global Clinical Affairs activities around medical device (MD)/IVD and Companion Diagnostics development, registration, and marketing.
Collaborate with internal project stakeholders, including Medical Affairs, Product Development, Quality, and Regulatory, to ensure compliance with organizational SOPs and international regulations.
Review and contribute to non-clinical QIAGEN documents and represent Clinical Affairs on multi-functional teams to ensure requirements are met for IVDR/FDA and ROW compliance.
Requirements
A Master's degree in Life Sciences with a minimum 3 years' employment experience with in vitro diagnostic devices and/or a clinical setting. Experience within oncology and/or companion diagnostics is preferred.
Working knowledge of regulatory requirements and clinical practice guidelines, including FDA CFR, ICH GCP, ISO20916, ISO14971, ISO13485, MDR, IVDR, MedDev, MDCG, CLSI guidelines, CTS, GHFT/IMDRF.
Good understanding of project management, proficiency in prioritizing work under tight and challenging deadlines within budget and in compliance with organizational SOPs and international regulations.
What We Offer
At QIAGEN, we value our employees and strive to create a collaborative, safe, and engaging workplace. We offer opportunities for growth and development, and we are committed to creating a diverse environment.
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