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MillenniumSoft Inc Logo MillenniumSoft Inc · IT - Administration

Analyst 1, Requirements Analysis

United States, San Diego · Job Posted January 11, 2026
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Job Description

The role involves conducting post-market product data analysis, creating necessary documentation, and ensuring compliance with regulatory standards. The candidate will work closely with internal teams to manage post-market surveillance processes, monitor safety signals, and propose corrective actions when necessary. This position requires collaboration across departments and interaction with executive management, contributing to safety surveillance, data analysis, and reporting.

Job Responsibility

  • 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

Requirements

  • Minimum of 2 years of relevant business experience
  • Experience in data analysis, signal detection, and summarizing data into graphs and statistics
  • Experience with post-market surveillance, complaints, and service management is preferred
  • Experience in the medical device industry or an FDA-regulated environment is preferred
  • Familiarity with Complaint Management Systems and technical documentation is preferred
  • Excellent written and verbal communication skills
  • Strong organizational and time management skills
  • Ability to self-manage in a complex, time-sensitive environment
  • Intermediate to advanced MS Excel skills (pivot tables, VLOOKUP, formulas)
  • Ability to effectively collaborate with cross-functional team members
  • Project management skills with strong electronic record-keeping abilities
  • Bachelor’s degree in mathematics, engineering, business, or a related field
  • Advanced degree (MBA or MS) with a technical, scientific, or engineering focus is preferred
  • Knowledge of basic statistical analysis software (SAS, R, SPSS, SQL) is preferred
  • Understanding of risk management is preferred

Nice to have

  • Experience with post-market surveillance, complaints, and service management
  • Experience in the medical device industry or an FDA-regulated environment
  • Familiarity with Complaint Management Systems and technical documentation
  • Advanced degree (MBA or MS) with a technical, scientific, or engineering focus
  • Knowledge of basic statistical analysis software (SAS, R, SPSS, SQL)
  • Understanding of risk management
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