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Post Market Survelliance Analyst - Remote (Entry Level or 3 Years Exp) ID-21340

Position : Post Market Survelliance Analyst

Location : San Diego, CA

Duration : 12 Months

Total Hours/week : 40.00

1st Shift

Client : Medical Devices Company

Job Category : Engineering/Technical

Level of Experience : Mid-Level

Employment Type : Contract on W2 (Need US Citizens or GC Holders or GC EAD or OPT or EAD or CPT)

Summary

Job Description:

The Post Market Surveillance Analyst will collaborate with a team of statisticians, engineers and analysts in support of post market surveillance processes.

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Responsibilities
  • Conduct post market product data analysis and aid in creating necessary post market documentation such as post market surveillance plans and reports
  • 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.
  • Collaborates and interacts with internal teams, including teams representing Medical, R&D, Product Quality, Engineering and Supplier Quality. Regularly interacts with executive management.
  • Reviews and continuously executes the post market surveillance process. Extracts monthly post market quality data and helps in update of PMS reports
  • Performs post-market safety and surveillance activities including data analysis, tracking/trending and signal detection.
  • Summarizes trends, signals, and escalations.
  • Ensures appropriate identification and governance of complaint coding schemes. Links post-market quality systems to risk management files as appropriate.
  • Completes projects/other duties as assigned. Provides support during external and internal audits of the post market surveillance processes.

Skills And Competencies

  • Excellent written and verbal communication skills
  • Strong organizational skills, time management skills and ability to self-manage in a complex/ time sensitive environment
  • Project management skills and the ability to maintain excellent electronic records
  • Intermediate to advanced MS excel skills (Pivot tables, Vlookup, formulas).
  • Ability to effectively collaborate with team members across functional areas

Qualifications And Experience

  • Bachelor’s degree in mathematics, engineering, business or related field
  • An advanced degree (MBA or MS) and a concentration in a technical, scientific, engineering or related field is preferred
  • Minimum of 2 years of relevant business experience
  • An understanding of basic statistical analysis software packages (SAS, R, SPSS, SQL) is preferred.
  • A demonstrated analytical capability with the ability to summarize data into graphs, charts and statistics is required.
  • Demonstrated ability to identify issues in post-market surveillance, complaints and service is preferred.
  • Experience with analysis and signal detection in a large data set is preferred.
  • Understanding of Risk Management is preferred.
  • Prior experience in the medical device industry or an FDA regulated environment is preferred.
  • Experience with Complaint Management System and technical documents is preferred.
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