Compliance Officer:

This role effectively supports the complaint handling process and processes complaints with a focus on MDR & Vigilance reporting. 
It centers on determining the need of regulatory reporting (MDR, Medical Device Reporting, MPR and Vigilance Reporting) of Complaints to National Competent Authorities in US and OUS. 

Responsibilities of the Compliance Officer:

• Runs the decision tree for reportability to NCAs and documents decisions on reportability in the system. Prepares, generates and submits incident reports (MDR, MDV, etc.) upon adverse events and submits follow-up and final reports to U.S., European and International NCAs. 
• Works with local RA/QA representatives on determination and filing of foreign incident reports. Prepares responses to standard and extended requests from Competent Authorities. 
• Evaluate complaints to determine whether an adverse event report/Medical Device Reporting (MDR) is necessary in accordance with 21 CFR Part 803 Medical Device Reporting and 806 Corrections and Removals, Canadian regulations, European Vigilance Reporting (93/42/EEC) and any other worldwide regulatory requirements. 
• Ensures that incident reports to U.S., European and International NCAs are submitted within the regulatory timeframes. Documents rationale if incident reports are not required. 
•  Prepares, generates and submits incident reports (MDR,MDV, etc.) upon adverse events and submits follow-up and final reports to U.S., European and International NCAs 
• Works with local RA/QA representatives on determination and filing of foreign incident reports. 
• Complete all required customer complaint/adverse event related documentation.