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EU MDR Complaints Data Specialist

EU-MDR Complaints Data Specialist – you can call it as Post Markey Surveillance Data Analyst (Official JD attached)

Notes from hiring manager below:

 

  • Responsible for Periodic Safety Update report - for EUMDR - tons of data - complaints by lot, by product, what’s reportable, whats not, whats the frequency, what was the outcome, number of NCRs, and they have to prepare this report and data from other reports and it goes into 60 - 70 pages in some cases 100 pages (they get a lot of this information from ETQ, access the CAPA log, the NC log, TMS Web for some things, compliance reporting data, clinical evaluation reports they would have to look at, risk management documents) all of this feeds into this report - we need someone to create this report - the people doing complaint investigations are doing it as a side activity so theyre getting really behind on complaints we have a 200 complaint back log because this report is taking up so much time from the team –
  • We might need someone who is comfortable in presenting data using simple tools like Excel, Pareto Charts, Histograms - but not super fancy like coding or Python - some experience in data analysis and very good experience in EUMDR would be a plus

 

  • We just finished angioseal and will start femoseal next week
  • Next will be destination
  • This is going to be reoccurring every single 

 

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