Chris Harris

About Chris Harris

Dynamic and skilled Project/Program Manager and certified Scrum Master with Lean/Six…

Experience

1. Analyst Ii

   Olympus Corporation

   Sep 2023 — Present

   As a Global MDR Submission Analyst II OSTA team member, I am responsible for timely regulatory reporting assessments and reassessments of global complaints, preparation and submission of initial/importer/supplemental MDR reports for post market activities per 21CFR803. Performs follow-up to obtain additional information for Adverse Events by collaborating with Field Specialists, Sales Representatives, Engineers, Technicians, Clinicians, and Customers directly. Performs routine assignments with minimal direction from manager; requires general instruction for new or special assignments from Manager. As an Analyst II, I maintain quality documents to ensure compliance with global medical device guidance documents. The Analyst II requires working knowledge of Medical Device Quality Systems regulations including ISO 13485, 21CFR820, and 21CFR803.Job Duties* Review incoming complaints to determine the facts of the case.* Verify information including information available in ancillary systems data sources.(For example: Datasweep, SAP).* Performs follow-up to obtain additional information for Adverse Events by collaborating with Field Specialists, Sales Representatives, Engineers, Technicians, Clinicians, and Customers directly.* Conducts timely initial MDR reportable assessment/ submission per 21CFR803.* Conducts timely re-assessments when new information has been received to determine if an initial or supplemental MDR is required per 21CFR803.* Assist with preparation and submission of FDA Additional Information responses, and associated documentation to the FDA and Manufacturing Business Centers (MBCs).* Assist Global MDR Submission Management in the successful identification and resolution of quality issues associated with complaints.* Key Team player working closely with other Global MDR Submission Associates.* Perform other duties as assigned.

Education

• North Central University

  Bachelor of Science - BS