Senior Medical Writer / Senior Project Manager, Clinical Evaluation
Core
Senior Medical Writer / Senior Project Manager responsible for creating Clinical Evaluation Plans, Reports, and SSCP documents to support EU CE Marking submissions for medical devices.
Role type
Senior IC medical writer and project manager (regulatory)
Builds
Regulatory submissions for CE Marking of new and existing medical devices
Domain
Medical devices / Regulatory Affairs / EU MDR
Required skills
Clinical evaluation planning, regulatory document creation, clinical evidence analysis, project management, risk mitigation, stakeholder communication, audit response, strategic regulatory guidance
Preferred skills
Cardiovascular device knowledge, advanced degree (Master's/PhD/MD/RN/PharmD), 5+ years clinical/regulatory experience, 3+ years CER development
Technologies
MEDDEV 2.7/1 Rev 4, MDD, MDCG Guidance, EU MDR 2017/745, project management tools
Responsibilities
Create and maintain Clinical Evaluation Plans and Reports, identify and summarize clinical evidence, manage project timelines and risks, facilitate cross-functional communication, lead regulatory responses to Notified Body questions, support internal/external audits, provide strategic guidance on regulatory requirements
Seniority
Senior, hands-on IC