What are the responsibilities and job description for the Complaints Handler - Medical Devices position at Advantage Technical?
Complaint Determination Associate
Location: Remote
Pay Rate: $31.00 an hour or about $63,000 a year
Job Type: 6 month contract with opportunity to extend
Position Overview
The Complaint Determination Associate operates under the guidance of the Team Lead, Complaint Determination, within Global Product Monitoring. This role is responsible for executing the complaint determination process to ensure accurate, consistent, and compliant decisions in alignment with global regulatory requirements.
The ideal candidate will demonstrate strong analytical skills, attention to detail, and the ability to manage multiple tasks in a fast-paced, regulated environment.
Key Responsibilities
- Review and assess inquiry records to determine whether they meet the definition of a medical device complaint
- Execute the complaint determination process in compliance with established global regulations and internal procedures
- Categorize complaint cases appropriately to support downstream investigation and resolution activities
- Assign non-complaint feedback to appropriate categories to enable accurate trending and reporting
- Reassess inquiry records when additional information becomes available
- Maintain accurate and complete documentation of all complaint determination activities
- Support additional complaint handling responsibilities as needed
Required Skills & Competencies
- Working knowledge of Quality System Regulations (QSR) and/or ISO 13485 preferred
- Familiarity with complaint handling processes within the medical device industry preferred
- Experience with systems such as TrackWise and Salesforce CRM preferred
- Proficiency in Microsoft Office Suite
- Strong written and verbal communication skills
- High attention to detail with the ability to maintain accurate records
- Strong organizational and time management skills
Leadership & Interpersonal Skills
- Ability to effectively manage priorities and work independently with minimal supervision
- Strong problem-solving skills, including the ability to navigate interpersonal challenges
- Ability to collaborate effectively in a team environment
Education & Experience
- Prior experience in medical device complaint handling or a related regulated environment preferred
Salary : $63,000