Complaint Specialist - Medical Device
Atrium Staffing, Princeton, NJ, United States
Client Overview:
Our client is a growing medical device company focused on delivering innovative healthcare solutions. The organization operates in a highly regulated environment and prioritizes product quality, compliance, and patient safety. They are looking to add a
Complaint Specialist – Medical Device
to their team.
Salary/Hourly Rate:
$29/hr - $33/hr
Position Overview:
This is a remote contract role supporting complaint handling and post-market activities. The Complaint Specialist – Medical Device will be responsible for reviewing product-related inquiries, determining complaint status, and ensuring accurate documentation in alignment with FDA regulations and internal quality systems. The Complaint Specialist – Medical Device will play a key role in maintaining compliance and supporting product monitoring efforts.
Responsibilities of the Complaint Specialist – Medical Device:
Review product-related inquiries to determine complaint eligibility.
Categorize complaint and non-complaint cases to support investigation, trending, and reporting.
Ensure all documentation is complete, accurate, and compliant with internal procedures and regulatory requirements.
Reassess cases when additional information becomes available.
Collaborate with the Quality and Regulatory teams to support complaint handling processes.
Required Experience//Skills for the Complaint Specialist – Medical Device:
Should have experience in a regulated industry such as medical device, pharmaceutical, or biotech.
Strong attention to detail and ability to follow structured processes.
Effective written and verbal communication skills.
Preferred Experience//Skills for the Complaint Specialist – Medical Device:
Experience with complaint handling, post-market surveillance, CAPA, or quality systems is preferred.
Education Requirements:
Bachelor’s degree is preferred or equivalent relevant experience.
Benefits:
Atrium Care Package available, upon eligibility (including healthcare plans, discount programs, and paid time off).
Our client is a growing medical device company focused on delivering innovative healthcare solutions. The organization operates in a highly regulated environment and prioritizes product quality, compliance, and patient safety. They are looking to add a
Complaint Specialist – Medical Device
to their team.
Salary/Hourly Rate:
$29/hr - $33/hr
Position Overview:
This is a remote contract role supporting complaint handling and post-market activities. The Complaint Specialist – Medical Device will be responsible for reviewing product-related inquiries, determining complaint status, and ensuring accurate documentation in alignment with FDA regulations and internal quality systems. The Complaint Specialist – Medical Device will play a key role in maintaining compliance and supporting product monitoring efforts.
Responsibilities of the Complaint Specialist – Medical Device:
Review product-related inquiries to determine complaint eligibility.
Categorize complaint and non-complaint cases to support investigation, trending, and reporting.
Ensure all documentation is complete, accurate, and compliant with internal procedures and regulatory requirements.
Reassess cases when additional information becomes available.
Collaborate with the Quality and Regulatory teams to support complaint handling processes.
Required Experience//Skills for the Complaint Specialist – Medical Device:
Should have experience in a regulated industry such as medical device, pharmaceutical, or biotech.
Strong attention to detail and ability to follow structured processes.
Effective written and verbal communication skills.
Preferred Experience//Skills for the Complaint Specialist – Medical Device:
Experience with complaint handling, post-market surveillance, CAPA, or quality systems is preferred.
Education Requirements:
Bachelor’s degree is preferred or equivalent relevant experience.
Benefits:
Atrium Care Package available, upon eligibility (including healthcare plans, discount programs, and paid time off).