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Complaint Specialist II
- Posted: 01/09/2025
- Salary: Competitive
- Location: Remote
- Job Type: Contract
The Complaint Specialist II will focus on the complaint handling process. This individual will input and evaluate customer complaints in our clients complaint management system. This individual will also participate in and coordinate investigations, update records, provide customer responses and ensure timely closure of complaints in accordance with FDA (US). The complaint specialist reports directly to the Compliant Management, under the Director of Quality and Regulatory Compliance.
Qualifications:
• 3 years of experience in medical device complaint handling and/or medical device compliance, preferably both.
• Experience with/or understanding of, the overall business environment, quality management systems and related regulations including:
o FDA 21 CFR 803
o FDA 21 CFR 806
o FDA 21 CFR 820,198
o ISO 13485:2016
• Familiarity with electronic quality management systems
Qualifications:
• 3 years of experience in medical device complaint handling and/or medical device compliance, preferably both.
• Experience with/or understanding of, the overall business environment, quality management systems and related regulations including:
o FDA 21 CFR 803
o FDA 21 CFR 806
o FDA 21 CFR 820,198
o ISO 13485:2016
• Familiarity with electronic quality management systems