Complaint Support Specialist

This is a fully remote position, open to applicants in United States.

📋 Description

• Receive and assess complaints pertaining to medical devices.

• Investigate complaints by collecting pertinent information, analyzing data, and performing root cause analysis.

• Engage directly with customers to gather information, address their concerns, and provide updates regarding the resolution of complaints.

• Act as a liaison between the Therapy Support and Quality departments to enhance customer satisfaction and ensure regulatory compliance.

• Ensure that complaint investigations are thorough, precise, and concluded promptly.

• Collaborate with cross-functional teams—including Therapy Support, Quality, Regulatory, and Product—to address complaints effectively.

• Maintain adherence to relevant regulations and standards, including FDA 21 CFR Part 820 and ISO 13485.

• Prepare for and participate in both internal and external audits.

• Contribute to initiatives aimed at cross-functional process improvements.

⛳️ Requirements

• Bachelor’s degree is preferred in a relevant discipline such as biomedical engineering, life sciences, or a similar field; relevant work experience may be accepted in place of a degree.

• Minimum of 2 years of experience within an FDA-regulated environment (drugs, biologics, medical devices, or similar products).

• At least 3 years of experience in direct communication with patients or customers of medical devices.

• Comprehensive knowledge of ISO 13485 and GMP regulations that govern medical device manufacturing.

• Excellent analytical and problem-solving abilities.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Comprehensive health, dental, and vision insurance plans.

• Retirement savings plan with company match.

• Generous paid time off and holiday policy.

• Opportunities for professional development and growth.