Company Overview: Abbott is a global healthcare leader with a broad portfolio of life-changing technologies in diagnostics, medical devices, nutritionals, and branded generic medicines. Abbott's innovations help people live healthier lives across 160 countries. With a focus on continuous improvement and new breakthroughs, Abbott is dedicated to enhancing the health of people worldwide.
The Senior Medical Writer/Project Manager (Vascular Clinical Evaluation Products) plays a critical role in supporting regulatory affairs submissions for CE Marking of new medical devices and maintaining CE Marks for existing devices. This position involves a deep understanding of clinical evaluation processes, regulatory guidelines, and product knowledge to develop and maintain Clinical Evaluation Reports (CERs) and related documents for medical devices. As a subject matter expert, this person will guide medical writers and work cross-functionally to manage the necessary documentation and regulatory requirements throughout a device’s lifecycle.
Clinical Evaluation Documentation:
Regulatory and Compliance:
Project Management & Communication:
Collaboration & Audit Support:
This is a significant opportunity to join a leading healthcare company and contribute to the safety and performance evaluation of cutting-edge medical devices. The role provides a blend of scientific expertise, regulatory knowledge, and project management, ensuring critical regulatory submissions are successfully completed for new and existing medical devices.
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