Complaint Specialist – Medical Device

About Atrium:

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).

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As a woman-owned firm, we value diversity. We are an equal opportunity and affirmative action employer and will consider all applications without regard to race, sex (including gender, pregnancy, sexual orientation and gender identity), age, color, religion or creed, national origin or ancestry, veteran status, disability (physical or mental), genetic information, citizenship or any other characteristic protected by law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Candidates who apply for roles through the Atrium website will be added to our candidate pool and may be considered for additional roles of a similar title. Please contact us to request an accommodation.
EOE/M/F/D/V/SO