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

• 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.

Skills & Certifications

• 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.

Eligibilities & qualifications

• 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.