Quality Professional(Medical Device Reporting, Complaint Handling)

Commercial Product Quality (CPQ) – Medical Device Reporting (MDR)

Job description:
assess andmake decisions onmedical devicereporting(Medical Device Report(MDR)-MedWatch Form
3500A), in accordance with 21 CFR 803, and
documenting those decisions.
EUAuthorized
Representative or Regional Unit.
Laboratory Solutions (LS)
product lines.
edicalDeviceReport (MDR)
/Medical
Device Vigilance Report (MDVR)/Medical Device Problem Report (MDPR-Canada)reporting and
trending.
LS product lineissues.
Provide CPQ support for LS Product Health Teams.
Display of a high level of critical thinking in bringing
successful resolution to high-impact, complex, and/or cross-functional problems
is expected. 
Demonstrate a significant knowledge of organization's business
practices and issues faced and contributions to problem resolution of those
issues.

Requirements:
9-10 years of experience with Medical Device Reporting (US and
Outside of the US)
People Management
Good writing, communication and organizational skills necessary.

Key Working Relationships: Primarily
intra organizational contacts and external contacts.