Post Market Survelliance Analyst - Remote

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)

Job Description:

Summary

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.