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The role involves conducting post-market product data analysis, creating necessary documentation, and ensuring compliance with regulatory standards. The candidate will work closely with internal teams to manage post-market surveillance processes, monitor safety signals, and propose corrective actions when necessary. This position requires collaboration across departments and interaction with executive management, contributing to safety surveillance, data analysis, and reporting.
Job Responsibility:
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
Requirements:
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
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
Nice to have:
Experience with post-market surveillance, complaints, and service management
Experience in the medical device industry or an FDA-regulated environment
Familiarity with Complaint Management Systems and technical documentation
Advanced degree (MBA or MS) with a technical, scientific, or engineering focus
Knowledge of basic statistical analysis software (SAS, R, SPSS, SQL)