Quality Professional(Medical Device reporting, Complaint Handling)

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.