Analyst 1, Requirements Analysis

MILLENNIUMSOFT

San Diego, CA

Roles & Responsibilities

Conduct post-market product data analysis and prepare post-market documentation, including surveillance plans and reports.
Ensure the adequacy of post-market surveillance documentation, focusing on regulatory compliance and technical/statistical soundness.
Collaborate with internal teams such as Medical, R&D, Product Quality, Engineering, and Supplier Quality; regularly interact with executive management.
Review and execute post-market surveillance processes continuously, including extracting monthly post-market quality data and updating PMS reports.
Perform post-market safety and surveillance activities, including data analysis, tracking/trending, and signal detection.
Summarize trends, signals, and escalations.
Govern complaint coding schemes and link post-market quality systems to risk management files.
Support external and internal audits of post-market surveillance processes.
Complete projects and other assigned duties.

Experience Required

Minimum of 2 years of relevant business experience.
Experience in data analysis, signal detection, and summarizing data into graphs and statistics.
Experience with post-market surveillance, complaints, and service management is preferred.
Experience in the medical device industry or an FDA-regulated environment is preferred.
Familiarity with Complaint Management Systems and technical documentation is preferred.

Skills & Certifications

Excellent written and verbal communication skills.
Strong organizational and time management skills.
Ability to self-manage in a complex, time-sensitive environment.
Intermediate to advanced MS Excel skills (pivot tables, VLOOKUP, formulas).
Ability to effectively collaborate with cross-functional team members.
Project management skills with strong electronic record-keeping abilities.

Eligibilities & qualifications

Bachelor's degree in mathematics, engineering, business, or a related field.
Advanced degree (MBA or MS) with a technical, scientific, or engineering focus is preferred.
Knowledge of basic statistical analysis software (SAS, R, SPSS, SQL) is preferred.
Understanding of risk management is preferred.

Apply

Vacancy posted 4 days ago

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