Commercial Product Quality (CPQ)
– Medical Device Reporting (MDR)
Job description:
assess and make decisions on medical device reporting (Medical Device Report(MDR)-MedWatch Form
3500A), in accordance with 21 CFR 803, and
documenting those decisions.
EU Authorized
Representative or Regional Unit.
Laboratory Solutions (LS)
product lines.
edical Device Report (MDR)
/Medical
Device Vigilance Report (MDVR) / Medical Device Problem Report (MDPR-Canada) reporting and
trending.
LS product line issues.
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.
