Analyst 1, Requirements AnalysisMILLENNIUMSOFT • San Diego, CA, United States
Analyst 1, Requirements Analysis
MILLENNIUMSOFT • San Diego, CA, United States
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job_description.job_card.job_descriptionMinimum 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. 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. 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.
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
Skills & Certifications
Eligibilities & qualifications
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