Post Market Survelliance Analyst - Remote (Entry Level or 3 Years Exp)

Position Overview

Position: Post Market Surveillance Analyst | Location: San Diego, CA | Duration: 12 Months | Total Hours/Week: 40 | Shift: 1st Shift | Employment Type:Contract on W2(Need US Citizens or GC Holders or GC EAD or OPT or EAD or CPT). The Post Market Surveillance Analyst will collaborate with a team of statisticians, engineers, and analysts in support of post market surveillance processes.

Key Responsibilities

• Conduct post market product data analysis and assist in creating necessary post market documentation such as surveillance plans and reports.
• Ensure the adequacy of documentation for post market surveillance activities in terms of regulatory compliance and technical/statistical soundness, and present results with proposed escalations, corrective, and preventative actions as required.
• Collaborate and interact with internal teams including Medical, R&D, Product Quality, Engineering, and Supplier Quality, while regularly interfacing with executive management.
• Review and continuously execute the post market surveillance process by extracting monthly quality data and updating PMS reports as needed.
• Perform post-market safety and surveillance activities including data analysis, tracking/trending, and signal detection, and summarize trends, signals, and escalations.
• Ensure proper identification and governance of complaint coding schemes and link post-market quality systems to risk management files as appropriate.
• Complete projects and other duties as assigned, and provide support during external and internal audits of post market surveillance processes.

Required Qualifications

• Bachelor’s degree in mathematics, engineering, business, or a related field.
• Minimum of 2 years of relevant business experience.
• Excellent written and verbal communication skills.
• Strong organizational and time management skills with the ability to self-manage in a complex, time-sensitive environment.
• Intermediate to advanced MS Excel skills (including pivot tables, VLOOKUP, and formulas).
• Project management skills and the ability to maintain excellent electronic records.
• Demonstrated analytical capability with the ability to summarize data into graphs, charts, and statistics.

Preferred Qualifications

• An advanced degree (MBA or MS) with a concentration in a technical, scientific, engineering, or related field.
• Familiarity with basic statistical analysis software packages such as SAS, R, SPSS, or SQL.
• Demonstrated ability to identify issues in post-market surveillance, complaints, and service.
• Experience with analysis and signal detection in large data sets.
• Understanding of risk management principles.
• Prior experience in the medical device industry or an FDA-regulated environment.
• Experience with Complaint Management Systems and technical documentation.