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Sr Product Safety

2 months ago

Gainesville, United States Exactech Full time

The Senior Product Safety & Surveillance Analyst is an individual contributor that is responsible to perform active surveillance of product safety and performance for orthopedic device implants and instrumentation.

Key Responsibilities
  • Actively monitor and analyze Post Market Surveillance data and trends
    • Develop and establish effective methods to collect user data and detect product safety signals from various clinical & post-market data sources
    • Perform statistical analysis of clinical & post-market data to provide as an input to periodic product performance review meetings
    • Utilize various accepted statistical methods and techniques to perform statistically sound analysis of available post-market data
  • Supports Risk management processes and activities by preparing and reviewing the data and statistical analysis of Health Hazard Evaluations (HHE)
  • Support statistical analysis of product failure mode data for various product families, including conducting advanced statistical analyses and writing statistical methods and results sections.
  • Provide support to related Post Market Surveillance activities such as preparation of reports for surveillance and collating reports for review of product quality, data, risk assessment, etc.
  • Participate in preparation, analysis, and writing of ad-hoc and aggregate regulatory inquiries and reports
  • Participate on project teams to provide statistical strategy and planning support as required over the duration of the project. May provide statistical input and support for other Exactech functional areas as required (e.g. Quality Assurance, Regulator Affairs, & Clinical Affairs)
  • Participating in continuing biostatistics education and maintaining professional memberships/activities.
  • Assist and support other employees, teams, and sales personnel as necessary.
  • Practice Exactechs Values & Mission
  • Know and apply the Quality System and any appropriate Federal and International standards