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
? 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.