Risk Management Subject Matter Expert

3 days ago


Cincinnati, Ohio, United States Advanced Clinical Full time
Key Responsibilities
  • Conduct thorough gap assessments of existing usability and risk management documentation against EU MDR requirements, ISO 14971:2019, and IEC 62366-1:2015.
  • Provide risk management leadership, guidance, and expertise throughout remediation projects.
  • Develop and implement efficient processes, procedures, practices, tools, and technologies to foster continuous improvement in risk management.
  • Lead the development and implementation of KPIs and metrics for the risk management process.
  • Support the post-market surveillance team by creating HIAs and HHEs.

Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations.



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