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Ensuring the adequacy of the documentation of post market surveillance activities in terms of regulatory compliance and technical/statistical soundness, presents results and proposes escalations, corrective, and preventative actions as required. Conduct post market product data analysis and aid in creating necessary post market documentation such as post market surveillance plans and reports.

Position : Post Market Survelliance Analyst Location : San Diego, CADuration : 12 MonthsTotal Hours/week : 40.001st ShiftClient : Medical Devices CompanyJob Category : Engineering/TechnicalLevel of Experience : Mid-LevelEmployment Type : Contract on W2 (Need US Citizens or GC Holders or GC EAD or OPT or EAD or CPT)Job Description:SummaryThe Post Market Surveillance Analyst will collaborate with a team of statisticians, engineers and analysts in support of post market surveillance processes.Responsibilities<ul><li>Conduct post market product data analysis and aid in creating necessary post market documentation such as post market surveillance plans and reports</li><li>Ensuring the adequacy of the documentation of post market surveillance activities in terms of regulatory compliance and technical/statistical soundness, presents results and proposes escalations, corrective, and preventative actions as required.</li><li>Collaborates and interacts with internal teams, including teams representing Medical, R&D, Product Quality, Engineering and Supplier Quality. Regularly interacts with executive management.</li><li>Reviews and continuously executes the post market surveillance process. Extracts monthly post market quality data and helps in update of PMS reports</li><li>Performs post-market safety and surveillance activities including data analysis, tracking/trending and signal detection.</li><li>Summarizes trends, signals, and escalations.</li><li>Ensures appropriate identification and governance of complaint coding schemes. Links post-market quality systems to risk management files as appropriate.</li><li>Completes projects/other duties as assigned. Provides support during external and internal audits of the post market surveillance processes.</li></ul>Skills and Competencies<ul><li>Excellent written and verbal communication skills</li><li>Strong organizational skills, time management skills and ability to self-manage in a complex/ time sensitive environment</li><li>Project management skills and the ability to maintain excellent electronic records</li><li>Intermediate to advanced MS excel skills (Pivot tables, Vlookup, formulas).</li><li>Ability to effectively collaborate with team members across functional areas</li></ul>Qualifications and Experience<ul><li>Bachelor's degree in mathematics, engineering, business or related field</li><li>An advanced degree (MBA or MS) and a concentration in a technical, scientific, engineering or related field is preferred</li><li>Minimum of 2 years of relevant business experience</li><li>An understanding of basic statistical analysis software packages (SAS, R, SPSS, SQL) is preferred.</li><li>A demonstrated analytical capability with the ability to summarize data into graphs, charts and statistics is required.</li><li>Demonstrated ability to identify issues in post-market surveillance, complaints and service is preferred.</li><li>Experience with analysis and signal detection in a large data set is preferred.</li><li>Understanding of Risk Management is preferred.</li><li>Prior experience in the medical device industry or an FDA regulated environment is preferred.</li><li>Experience with Complaint Management System and technical documents is preferred.</li></ul>

Millenniumsoft

Post Market Survelliance Analyst - Remote

Analysis Skills

Business Administration

Communication Skills

Corrective Action

Data Analysis

Data Sets

Documentation

External Audit

FDA (Food and Drug Administration)

IBM SPSS Statistical Package

Identify Issues

Internal Audit

Market Analysis

Mathematics

Medical Equipment

Microsoft Excel

Organizational Skills

Pivot Tables

Presentation/Verbal Skills

Product Engineering

Project/Program Management

Quality Engineering

R Programming Language

Record Keeping

Regulatory Compliance

Research & Development (R&D)

Risk Management

SQL (Structured Query Language)

Statistical Analysis System (SAS)

Statistics

Surveillance

Systems Administration/Management

Team Player

Technical Writing

Time Management

Trend Analysis

Vlookups

Writing Skills

IRecruitee

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Post Market Survelliance Analyst - Remote Millenniumsoft

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