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