Analyst 1, Requirements Analysis

Roles & Responsibilities

• Conduct post-market product data analysis and prepare post-market documentation, including surveillance plans and reports.
• Ensure the adequacy of post-market surveillance documentation, focusing on regulatory compliance and technical / statistical soundness.
• Collaborate with internal teams such as Medical, R&D, Product Quality, Engineering, and Supplier Quality; regularly interact with executive management.
• Review and execute post-market surveillance processes continuously, including extracting monthly post-market quality data and updating PMS reports.
• Perform post-market safety and surveillance activities, including data analysis, tracking / trending, and signal detection.
• Summarize trends, signals, and escalations.
• Govern complaint coding schemes and link post-market quality systems to risk management files.
• Support external and internal audits of post-market surveillance processes.
• Complete projects and other assigned duties.

Experience Required

Skills & Certifications

Eligibilities & qualifications