Medical Device Quality & Complaints Specialist

Edwards Lifesciences Gruppe; Indiana; Hybrid; USD 65,000 - 100,000; Full time

Job summary

Edwards Lifesciences is seeking a Quality Compliance professional to support complaint handling and regulatory reporting within our Transcatheter Mitral and Tricuspid Therapies (TMTT) unit. You will assess complaints, coordinate investigations, and ensure compliance with MDR and GDP across the product lifecycle.

You will collaborate with Product Safety, Engineering and other departments to drive investigations, implement improvements, and maintain patient safety and regulatory standards in a

Qualifications

• 3 years’ experience in complaint handling or equivalent
• Experience with Medical Device Reporting (MDR) to FDA or equivalent
• Strong written and verbal communication skills
• Understanding of GDP and good documentation practices (GDP)

Responsibilities

• Assess complaint information and determine if it qualifies as a complaint; escalate as needed
• Manage customer relationships during investigation and resolution
• Coordinate input from Product Safety, Engineering and other units for investigations
• Identify problems and lead process improvement initiatives
• Evaluate complaints for MDR and prepare submissions to FDA
• Summarize investigation findings, product analysis, IFU, labeling and training materials
• Prepare and submit final customer communications
• Support audit activities and other duties as assigned by Leadership

Skills

Complaint handling

MS Office Suite

Medical device

Communications skills

Regulatory knowledge

Tools

GDP knowledge

Job description

Edwards Lifesciences is seeking a Quality Compliance professional to support complaint handling and regulatory reporting within our Transcatheter Mitral and Tricuspid Therapies (TMTT) unit. You will assess complaints, coordinate investigations, and ensure compliance with MDR and GDP across the product lifecycle.

You will collaborate with Product Safety, Engineering and other departments to drive investigations, implement improvements, and maintain patient safety and regulatory standards in a