Responsibilities:
- Analyse and interpret customer calls and emails
- Apply regulatory decision trees to determine complaints
- Filing adverse events with the appropriate regulatory agencies
- Perform complaint investigations and complete reports
- Cooperate with health operations to acquire appropriate data for documentation of events
- File/maintain reports to assure availability and retrieval for Notified Body and regulatory auditing
- Electronically maintain complaint database for tracking complaints
- Knowledge of FDA QSR's (21 CFR 820)
- Knowledge of ISO 13485 with regards to handling complaints (required)
Education/Training:
- 3 years of experience is required
- Undergraduate degree or higher
- Extensive verifiable experience in lieu of degree
