Complaint Intake Specialist
1 week ago
Key Skills: Medical Device, Compliant Management, Call Processing.
Roles & Responsibilities:
- Process case files according to Standard Operating Procedures (SOP).
- Receive initial complaints from various sources and ensure accurate data capture.
- Maintain knowledge of required information for technical and adverse event complaints to ensure compliance.
- Manage complaint records using designated safety systems.
- Review potential complaint data and perform timely intake and follow-up activities.
- Triage complaints for quality assurance and escalate potential safety issues.
- Adhere to corporate compliance guidelines and support audit activities.
- Evaluate and escalate safety issues to management as necessary.
- Create high-quality regulatory reports and meet internal and external quality standards.
Experience Requirement:
- 2 - 4 years of experience in complaint management within the medical device industry.
- Hands-on experience in handling technical and adverse event complaint records.
- Strong understanding of regulatory requirements and experience supporting audits and quality systems.
Education: B.Pharma, B. Sc., M.Sc., M Pharma.
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