Senior Medical Writer, Clinical Evaluation (on-site)
Core
Authoring Clinical Evaluation Plans/Reports, PMS/PMCF Plans/Reports, and regulatory documentation for Neuromodulation, CAHF, and Vascular medical devices.
Role type
Senior Medical Writer (Clinical Evaluation)
Builds
Clinical Evaluation Reports and regulatory submission documents for medical device product lifecycles
Domain
Medical Devices / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical study management, clinical evaluation reporting, risk management, technical writing, data analysis, project management, compliance with ISO13485/MDR/FDA guidelines
Preferred skills
Advanced degree in science/medicine, experimental design, clinical data interpretation, complaint handling, diagnostic instrumentation operation
Technologies
Word, Excel, PowerPoint, Outlook
Responsibilities
Write and contribute to Clinical Evaluation Plans/Reports and PMS/PMCF Plans/Reports; Evaluate and summarize clinical evidence from investigations and literature; Collaborate with Regulatory Affairs, R&D, and Quality Engineering; Review IFUs, Risk Management files, and physician training materials; Ensure compliance with applicable regulations and corporate SOPs
Seniority
Senior, hands-on IC
