Medical Device Complaint Investigator & Vigilance

envista; Venlo; On-site; EUR 60,000 - 90,000; Full time

Job summary

Envista's Complaint Handling & Vigilance Specialist evaluates each complaint for eligibility and reportability, conducts investigations following regulatory guidelines, and handles reporting and closure of complaints with supervisory support.

The role collaborates with Customer Service, Quality Assurance, and Postmarket Surveillance, manages workload, and may lead small projects while upholding industry standards and documentation practices.

Qualifications

• Bachelor's degree or equivalent work experience.
• Knowledge of medical device quality management systems 21CFR820, 21CFR803, ISO13485, MDSAP and other applicable regulations.

Responsibilities

• Evaluate complaints on eligibility, reportability and need for investigation.
• Report events to applicable competent authorities and notified body.
• Requests more information when needed from Customer Service.
• Perform investigations to confirm the complaint, determine the scope and find the root cause.
• Communicates outcomes to stakeholders, like customer service, Quality Assurance and Postmarket Surveillance.
• Manage their assigned tasks and workload.
• Acts as a resource for colleagues with less experience.
• May lead small projects with manageable risks and resource requirements.

Skills

Fluency in English

Microsoft Office

Time management

Education

Bachelor's degree or equivalent work experience

Tools

SAP

Job description

Envista's Complaint Handling & Vigilance Specialist evaluates each complaint for eligibility and reportability, conducts investigations following regulatory guidelines, and handles reporting and closure of complaints with supervisory support.

The role collaborates with Customer Service, Quality Assurance, and Postmarket Surveillance, manages workload, and may lead small projects while upholding industry standards and documentation practices.