Job Description
About this role:
iRhythm Technologies, Inc. is seeking a Data Analyst to support post‑market surveillance, complaint handling, and Quality System performance through data analysis, reporting, and visualization. This role is responsible for executing routine to moderately complex analyses using established tools, methods, and frameworks to support trending, investigations, and regulatory reporting activities.
The Data Analyst partners closely with Post‑Market Quality, and cross‑functional stakeholders to ensure data integrity, timely reporting, and clear communication of insights. Working under defined analytical standards and guidance, this role contributes to inspection readiness, management reviews, and continuous improvement initiatives by transforming post‑market data into accurate, actionable information.
Responsibilities:
- Design, create, and verify data reports, metrics, and visualizations of post-market surveillance data
- Support and facilitate post‑market surveillance data reviews under established frameworks
- Support complex investigations by performing analyses using defined methods
- Prepare analytical content for regulatory submissions under guidance and review
- Coordinate analyses of post-market data to identify and investigate product quality concerns
- Apply statistical techniques to test hypotheses in support of investigations and corrective and preventive actions (CAPA)
- Identify and recommend system and process improvements to enhance efficiency and effectiveness of data analysis activities
- Participate in regulatory audits, internal audits, and inspections to represent post-market surveillance analytics
- Perform other quality and regulatory-related duties as assigned
Required Qualifications:
- Bachelor’s Degree or Associate Degree in engineering, science, or technology
- 3 years of experience in business, manufacturing data analytics, data modeling or statistical modeling in a cGMP related industry
- Strong ability to acquire and manage data from enterprise systems
- Demonstrated proficiency with a business intelligence package such as BI tools such as Business Objects suite and Data Management tools such as Tableau
- Familiarity with at least one statistical programming package (e.g. Minitab) preferred
- Previous experience in medical devices with working knowledge of ISO 13485, FDA 21 CFR 820, European Union MDD /MDR
- Strong analytical, problem solving, and presentation skills, and strong attention to detail
- Ability to work as part of a diverse team
- Effective verbal and written communication skills
