Senior Medical Writer / Senior Project Manager, Clinical Evaluation
Core
Create and maintain Clinical Evaluation Plans, Reports, and Safety/Performance summaries to support EU CE Marking submissions for medical devices.
Role type
Senior Medical Writer / Senior Project Manager (Clinical Evaluation)
Builds
Regulatory submissions for vascular medical devices in the EU
Domain
Medical Devices / Regulatory Affairs / Clinical Evaluation
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
EU MDR 2017/745 knowledge, clinical evaluation methodology, project management, medical/surgical terminology, regulatory response drafting, stakeholder communication
Preferred skills
Cardiovascular device knowledge, advanced degree (RN/PharmD/PhD/MD), 5+ years clinical/regulatory experience, CER development expertise
Technologies
Project management tools
Responsibilities
Independently create and maintain Clinical Evaluation Plans and Reports; Identify and summarize clinical evidence from investigations and literature; Manage project timelines and risks; Facilitate communication between internal teams and external vendors; Provide strategic guidance on regulatory requirements; Support audits and root cause analysis
Seniority
Senior, hands-on IC