Regulatory Affairs Engineer, Post-Market Surveillance
Core
Operate and improve the post-market surveillance (PMS) system across the medical device portfolio, ensuring consistent application of PMS SOPs and generating periodic reports for Notified Bodies.
Role type
Regulatory Affairs Engineer (Post-Market Surveillance)
Builds
Periodic post-market trend reports, literature search methodologies, and technical documentation sections for regulatory submissions.
Domain
Medical Devices / Regulatory Affairs / Post-Market Surveillance
Deliverable
dashboards & analysis
Required skills
Post-market surveillance process management, PMS SOP implementation, periodic reporting for Notified Bodies, EU MDR compliance, ISO 13485/14971 knowledge, cross-functional collaboration, process optimization, technical writing
Preferred skills
Experience with devices on market for several years, managing obligations across multiple risk classes, workflow automation, light scripting, Visual Studio Code, Azure DevOps, AI tool usage
Technologies
Visual Studio Code, Azure DevOps, AI tools (e.g., Claude)
Responsibilities
Run and maintain the PMS process across the device portfolio, implement and update the PMS SOP, produce periodic post-market trend reports and literature searches, prepare post-market sections of technical documentation for Notified Bodies, support regulatory owners on post-market questions
Seniority
Mid-level, hands-on IC
